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Technology Transfer Project Management Best Practices in the Era of COVID-19

Technology transfer is essential to advancing pharmaceutical products from development, through clinical and into commercial operation.  The complexity of transferring the production of a product from a sending unit to the receiving unit is challenging even in the best of conditions. Since the onset of the COVID-19 pandemic the industry has shifted into high gear to develop, test and manufacture diagnostic tests, vaccines and therapies. With these developments, the speed, challenges and stakes involved in technology transfer have reached new heights.

Given these challenges, I recently presented a webinar highlighting technology transfer project management best practices in the era of COVID-19, find the recording here .  I hope you enjoy the webinar and find the information helpful.

Following the webinar, I have received a number of questions. Responses to these questions are below.

Q: Has the supply chain been a major issue for these quick tech transfers during the pandemic?

A: Yes, definitely! The impacts are many. Let’s highlight a few here:

• Consumables: The supply chain is extremely tight for: PPE is chronically short. Vials, stoppers, caps are in critical shortage. Single use system consumable items can be a challenge. Specialized buffer and media can be in short supply.
• Capacity: Aseptic fill capacity is in very high demand. Every available line is being called into action to support production of vaccines and therapies for COVID. Viral Vector and plasmid production capacity is also extremely
• Labor: The market for skilled and experienced personnel is very tight. Companies are facing challenges to staff key roles to support COVID programs. It’s common to see companies pull together ‘A-teams’ to work on COVID projects, leaving gaps in other programs.

Q: What are the complications of working in a BARDA project?

A: The biggest challenge that I have seen in working with BARDA projects (and other government-funded programs) is the uneven pace of progress. A proposal for a great idea can sit for weeks or months waiting for government funding – and then when funding is approved the project is expected to immediately shift into hyperdrive to achieve extremely ambitious timelines. This poses challenges of keeping a core team in place and the project moving forward on a shoestring budget while awaiting funding – and then rapidly increasing staffing, equipment and materials when funding arrives. Of course, if funding is not approved, the project may get scrubbed if other sources of funding have not been lined up.

Q: Are there tasks that are needed to be done in parallel to optimize the timeline?

A: Yes! A successful project plan identifies critical path activities (those that must occur in sequence) schedules all other activities to occur as early as possible and in parallel with other activities, so as not to impact the critical path.

In the context of a tech transfer project, the overall ‘flow’ needs to progress through the major milestones as illustrated below, often with stage-gate reviews to demonstrate completion of each stage and readiness to proceed to the following stage.

For sure, within each of these stages, there is a multitude of activities that can and should be implemented in parallel. For example, during the planning phase, the overall effort of the Risk Assessment and Plan Development should be carried out as multiple parallel workstreams across all functional areas, and each of the inputs rolled up into a high-level plan.

Another opportunity to accelerate the schedule by working in parallel is to ‘pull forward’ key ‘long lead-time activities’ from future stages in the project and starting those very early in the project. Examples of these might include:

• Equipment selection and ordering (particularly long-lead and high-demand items such as fill lines, bioreactors, air handling units, etc.)
• Engineering studies to support any process changes (bioreactor design, formulation mixing, media selection, chromatography, filtration, etc.)
• Supply Chain Vendor Selection (Identifying suppliers that can support production at the new location / new scale, vendor audits and qualification, material equivalency studies, leachable and extractable studies, etc.)
• Staffing – assessment of local labor pool and hiring team leaders in key functional areas.

Q: What are the challenges of some less experienced companies developing products at a high pace?

A: Newly formed teams face a number of challenges – all of which are amplified by developing products a high rate of speed. A few considerations:

• Easy to say, not so easy to do. Laser-like alignment on achieving one goal dramatically increases the chances and speed of success in achieving that goal. Continuously engaging with the team to ensure all members of the team are aligned with the goal is the essential task of leadership.
• Swim lanes. Each member of the team needs to ‘own’ the duties, responsibilities and deliverables of their swim lane – and work cooperatively to support their teammates in adjacent swim lanes.
• Confidence that each team member is going to ‘own’ their swim lane in order to support the overall goal. Confidence builds as the team overcomes challenges and achieves successes on the road to their overall goal.
• Fail Fast & Learn. Identify high-risk items (technology, process, suppliers, etc.) and test them right away. Learn from the experience and pivot rapidly.
• Rapid innovation can be a jarring, zig-zag path as the team swims hard and fails fast. Agility is the ability of the team to rapidly communicate the need for change, adjust the plan to achieve the revised goal, re-orient all swim-lanes toward the updated goal, and get everyone swimming at full again.

Q: Are there differences with cell therapy tech transfers?

A: The answer to this question is highly dependent on the indication and the technology being employed. That said, two factors that play out-sized roles in the success of cell therapy tech transfers is the supply chain.

Supply Chain: Often times in cell therapy, the supply chain is a closed loop that starts and ends with the patient. Timelines are tight, and there is no room for error. Having a do-over is not an option when the patient is fighting advanced stages of a disease. A tech transfer project for a cell therapy product should develop a thorough supply chain map used by the sending unit, the planned supply chain map planned for the receiving unit and then conduct a thorough, cross-functional risk assessment for each step of the supply chain – as well as the supply chain as a whole. Key considerations include regulatory requirements, vendor qualification, packing system qualification, parameter monitoring system qualification, chain of custody and data integrity.

Batch Release: Cell therapy products often patients who are at very advanced stages of a disease, where every hour counts in delivering the treatment to the patient. Batch release for cell therapy products can be extremely challenging due to the variability of the starting materials and challenges in achieving optimum manufacturing process outcomes. Accordingly, a highly efficient batch release process must be implemented that employs a risk-based approach. This will enable a team can make the determination that the batch is safe and effective for patient treatment, while allowing certain steps of batch release deviations to remain open to enable deeper investigation and implementation of corrective and preventative actions.

Q: What technology can be used to facilitate technology transfers, particularly with COVID?

A: There are a plethora of tools designed to enable teams that are multi-site and/or virtual. Here are four categories of technology that have been very helpful in implementing tech transfer projects.

• Virtual Dry-Erase Board. Planning sessions, workshops, scheduling huddles, etc. are facilitated by dry erase board and a bunch of colored stickies. Today, this can be done virtually with software tools that enable scores of participants to simultaneously interact on a virtual dry erase board to draw, type, post stickies, keep lists, mind-map, and all kinds of helpful collaborative activities. These tools are as good as having everyone in the room.
• File Management tools. Having a shared space where all project documents are kept is essential. Tools that facilitate routine and version control are even better. Pushing documents back and forth by e-mail is inefficient and out of pace with technology.
• Cross-company Team Chat. Pretty much every company has a chat tool used to facilitate communication and productivity among members of the company. The same need for efficient communication and coordination among teammates is needed for tech transfer projects, but more often than not team members from Company A can’t chat with Company B, causing everyone to reach for their mobile phones to text each other. Good news. Many of the productivity platforms are enabling the creation of project spaces that allow internal and external teams to chat, voice call, video call and share documents.
• Virtual Presence Platforms.   One of the most effective methods of knowledge transfer for operator processes is hands-on training. The gold standard has been to have the receiving unit send teams to the sending unit site to receive hands-on training. This was not always possible and is less feasible in the age of COVID. There are a whole class of training tools that use virtual presence (3-d goggles, streaming video, SOPs with video clips, etc.) to enable the receiving unit to virtually experience operations at the sending site. In some cases, the virtual presence tools are even more powerful in that they can create narrated ‘first person’ views of how to perform complex operations.

We appreciate your interest in technology transfer and welcome the opportunity to continue the discussion.

View the full presentation:

About the Author

As Global Director of Process and Manufacturing Technology, Charlie Maher  leads CAI’s delivery of solutions that advance life science products through their lifecycle. Services include: Product development/QbD, development to clinical to commercial manufacturing scale-up planning/management, process and facility conceptual design, tech transfer, process validation, CMC regulatory support, in-service process engineering, aseptic processing, investigations and issue resolution, and supply chain management.

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What is technology transfer?

Technology transfer within the innovation ecosystem, technology transfer in the context of covid-19, technology transfer in action, related links, intellectual property and technology transfer.

Technology transfer supports the life cycle of technology, from inception to market diffusion and commercialization.

Intellectual property (IP) is an important instrument at the research and development level. It helps assure the ownership over intellectual findings and the capacity to control the use of IP in line with an institution's mission and core values.

IP is also a powerful business tool to gain position on the market and exclusivity over a new product or process. This makes it an important instrument to attract partners and potentially obtain return on research investment through development collaboration or licensing deals.

Understanding how IP serves technology transfer is the first step towards managing your technology transfer processes effectively.

Technology transfer (TT) is a collaborative process that allows scientific findings, knowledge and intellectual property to flow from creators, such as universities and research institutions, to public and private users. Its goal is to transform inventions and scientific outcomes into new products and services that benefit society. Technology transfer is closely related to knowledge transfer.

Read the full list of FAQs on technology transfer .

Video: Learn more about technology transfer and its relation to intellectual property.

Incentives in Technology Transfer

A practical guide on how to effectively encourage, recognize and reward researchers and technology transfer professionals.

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For successful technology transfer, universities and research institutions need to operate in an effective innovation ecosystem – an interconnected network of governmental, industry and research institutions and enabling factors (such as human capital, technology transfer structures, and sophistication of businesses and market). In such an ecosystem, the parties bring their resources and expertise together to collaboratively achieve innovation in the service of regional and economic development.

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WIPO has developed a flexible platform for innovation support and technology transfer In relation to the COVID-19 pandemic. The platform comprises evidence-based analysis, capacity development, institutional frameworks and policies, and related information and knowledge resources.

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Guest Column | June 22, 2023

Navigating regulatory guidelines for effective tech transfer.

By Bilel Khedir and Dalenda Bouslah, Opalia Recordati

The WHO defines technology transfer as a “logical procedure that controls the transfer of a process with its documentation and professional expertise between development and manufacturing sites or between manufacturing sites.” 1

From the FDA perspective, the technology transfer is “the process of transferring skills, knowledge, technologies, and manufacturing methods among governments and universities — and other institutions — to make sure that a wider range of users has access to scientific and technological developments. These users can, in turn, develop and use the technology to create new products, processes, applications, materials or services.” 2

The phases of a technology transfer project are: 3 project initiation, project planning , project execution, and project review and close-out.

According to ICH Q10, the knowledge transferred is the basis for manufacturing process, control strategy, process validation approach, and ongoing continual improvement. 4 However, the knowledge transferred can be divided into two categories: documented and undocumented knowledge. The second kind of knowledge is crucial for technology transfer success. Examples of undocumented knowledge include test frequencies of in-process controls or stress relaxation for tablets. 5

In this article, we will discuss some important aspects of a technology transfer project.

1. The Project Team

In the WHO guideline, the project team members are required to have “necessary qualifications and experience.” Thus, the transfer team (TT) should include members from many disciplines to allow for the representation of different perspectives. 5

A TT team can include, for example:

• Project manager
• Process engineer or production (production specialist)
• Pharmaceutical development specialist

2. The Project Management Plan

The WHO states in its guideline on TT that “There should be a project management plan which identifies and controls all the necessary activities identified at the start of the undertaking.” 1 The same guideline describes an important document, which in my opinion is key to determining the success of the TT: The Technology Transfer Protocol. The TTP should include: 3

• Key personnel and their responsibilities
• Parallel comparisons of materials, methods, and equipment
• The transfer stages with documentation that each critical stage has been satisfactorily accomplished before the next commences
• Identification of critical control points
• Experimental design and acceptance criteria for analytical methods
• Information on trial production batches, qualification batches, and process validation
• Change control for any process deviations encountered
• Assessment of the end product
• Arrangements for retaining samples of active ingredients, intermediates, and finished products and information on reference samples where applicable
• Conclusion, including signed-off approval by the project manager

3. Gap Analysis

The WHO defines a gap analysis in its draft guideline 2021 as “the identification of the critical elements of a process which are available at the SU [sending unit] but are missing in the RU [receiving unit] with the objective to assess which gaps have potential impacts on the process or the method and to mitigate those gaps, as appropriate.” 3

The gap analysis allows the RU to identify the actions necessary to reproduce the process being transferred. Many pharmaceutical professionals assume that the RU should have identical capabilities as the SU (equipment and premises, for example). However, the RU is not required to have identical capabilities (e.g., equipment), but should have similar capabilities that allow a successful transfer. This is clearly stated in the WHO guideline of 2011 1 : “The capabilities of the SU and at the RU should be similar, but not necessarily identical , and facilities and equipment should operate according to similar operating principles.”

The same perspective is also maintained in the WHO draft guideline of 2021: “ The technology transfer project should fulfill the following general principles and requirements. There should be[…] similar capabilities between the SU and RU, including but not limited to, facilities and equipment.” 2  In the case of equipment, the WHO provides in its guidelines the points to consider when conducting a comparison:

WHO 2011 Guideline: 1

• Minimum and maximum capacities
• Material of construction
• Critical operating principles
• Critical equipment components
• Critical quality attributes
• Range of intended use

WHO 2021 Guideline: 3

• Working principles
• Make and models
• Material of construction of contact surfaces

For the equipment, one guideline can be extremely helpful in the comparison: The FDA SUPAC Manufacturing Equipment Addendum . The TT team can use this guideline to demonstrate they have similar manufacturing equipment.

Once the gap analysis is accomplished, the RU will be able to decide whether to acquire new equipment or adapt the equipment it has. Decisions to adapt the process or equipment must be justified and scientifically sound, and this is generally determined through a risk analysis conducted by the RU TT team.

4. Risk Assessment

The risk assessment is a key step in the technology transfer. In fact, changes during the tech transfer may occur. The risk assessment can include many parameters (critical process parameters, manufacturing equipment, etc.). To demonstrate that the process is under control, the team must undertake a detailed documented risk analysis. The main objective of the risk analysis, in general, is to look for the areas where the risk is high and intensify the controls there.

The risk assessment is generally done using a failure modes and effects analysis (FMEA) tool, but there are novel approaches that integrate fault tree analysis (FTA) and FMEA to exploit advantages of both methods and minimize the drawbacks of each method when used alone. 6 The risk assessment will be divided into two phases:

• Phase 1: Identification of failure modes through FTA.
• Phase 2: Assessment of criticality using FMEA, where only the most critical failure modes will be selected.

Phase 1 and Phase 2 analyses will both be performed in a recursive way at three levels: system, component, and function:

• The system is the technology transfer project as a whole.
• The functions associated with the system are manufacturing process transfer and analytical methods transfer.
• The components may be, for example, aspects of the manufacturing function, such as mixing, granulation, tabletting, coating, and packaging. Components of analytical methods transfer include analytical validation (partial or complete) and comparative testing.

Performing the risk assessment using a combination of FMEA and FTA is well explained in References 6 and 7.

Examples of areas where risk analysis would be very useful are in stability and in manufacturing process and equipment. 

Stability data should be generated in principle from drug product made at the RU. On the other hand, in order to generate sufficient stability data, companies must spend time and money, and that might be an obstacle. However, with a science-based risk analysis, the tech transfer team may alleviate the work that needs to be done in this area. In fact, complex dosage forms are defined by the FDA as drug products that have complex release mechanisms, delivery systems, and manufacturing processes that are likely to be affected by the site transfer. Thus, if the applicant manages to demonstrate that the drug product transferred presents minor risk (e.g., an immediate release solid oral dosage form with high solubility), they can claim a site transfer without stability data at the RU (data will be submitted in the annual report).

The ISPE guideline for technology transfer proposes a risk-based classification of dosage forms that can be very helpful in elaborating a risk analysis.

Manufacturing Process and Equipment

The RU may be obliged to adapt the process or the equipment to its capabilities. In this kind of situation, the RU tech transfer team must conduct a risk analysis based on scientific data to demonstrate that the changes did not affect the quality of the product.

The specific tests and the amount and the type of data required to back up the risk analysis can be determined by referring to the SUPAC Guidelines of the FDA. 8 The first step is to define precisely the type of changes made in terms of process and/or type of equipment. The second step is to determine the level (level 1, 2, or 3, defined by the FDA) of the changes made according to the specific FDA Scale-up and Post-Approval Changes (SUPAC) guidances for immediate release, modified release, or semisolid drug products, as well as the SUPAC Manufacturing Equipment Addendum. Once the TT team has successfully defined the level of changes made, they will be able to decide which tests and documentation are needed according to SUPAC guidelines and include all the data used in the risk analysis.

Among the indicators of success of a technology transfer project as defined by the WHO, there are “full mastery of technology transferred,” “achievement of agreed quality standard,” and “more affordable price (more access to medicines).” 9 That being said, differences in the regulatory standards in the countries of the RU and SU may pose a significant barrier for technology transfer projects. Effective patient-centric and science-based communication between drug manufacturers and local regulatory authorities helps to achieve the ultimate goal of technology transfer, which is, in my opinion, easier access to quality drugs in emerging countries.

Acknowledgment:

The authors would like to thank Mohamed Rouahi, regulatory affairs manager at Opalia Recordati, for his input and insights.

• World Health Organization (WHO), 2011, WHO guidelines on transfer of technology in pharmaceutical manufacturing. Link: https://extranet.who.int/pqweb/sites/default/files/documents/TRS_961_Annex7_2011.pdf#:~:text =1.5%20Transfer%20of%20technology%20requires,development%2C%20production%20and%20 quality %20control .
• US Food and Drug Administration, (2021, October 18), FDA Technology Transfer https://www.fda.gov/about-fda/doing-business-fda/fda-technology-transfer
• World Health Organization (WHO), 2021, WHO guidelines on the transfer of technology in pharmaceutical manufacturing (Draft working document for comments). Link: https://cdn.who.int/media/docs/default-source/essential-medicines/norms-and-standards/qas20-869-transfer-of-technology.pdf
• International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human guideline Q10 on pharmaceutical quality system - Step 5, 2008 [cited 2023 May] LINK https://www.ema.europa.eu/en/documents/scientific-guideline/international-conference-harmonisation-technical-requirements-registration-pharmaceuticals-human_en.pdf
• A successful concept for Technology transfer in drug manufacturing, GMP-Verlag Peither AG. Link: https://www.gmp-publishing.com/media/pdf/a3/32/de/Reading_Sample-Successful_Concept_for_Technology_Transfer_in_Drug_Manufacturing.pdf
• Peeters, J. F. W., Basten, R. J., & Tinga, T. (2018). Improving failure analysis efficiency by combining FTA and FMEA in a recursive manner. Reliability engineering & system safety, 172, 36-44.
• Shafiee, M., Enjema, E., & Kolios, A. (2019). An integrated FTA-FMEA model for risk analysis of engineering systems: a case study of subsea blowout preventers. Applied Sciences, 9(6), 1192.
• International Society of Pharmaceutical Engineering. (2003). Technology Transfer Good Practice Guide
• Moon, S (2011) Pharmaceutical Production and Related Technology Transfer. World Health Organization. Link: https://apps.who.int/iris/handle/10665/44713

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CATEGORY GUIDE

Tech transfers in pharma: definitions and key processes in technology transfers.

Pharma and biotech companies are increasingly outsourcing production to reliable contract development and manufacturing organisations ( CDMOs ).

Tech Transfers are critical factor in these partnerships to be successful in developing, manufacturing and managing risk associated with moving manufacturing between sites.

What is a technology transfer?

In the pharmaceutical industry a technology transfer -more commonly known as a tech transfer – is a series of knowledge transfers on a drug product and its established manufacturing processes from development to commercial production.

The ICH Q10 guidance  explains the purpose of technology transfer as follows:

The goal of technology transfer activities is to transfer product and process knowledge between development and manufacturing, and within or between manufacturing sites to achieve product realisation. This knowledge forms the basis for the manufacturing process, control strategy, process validation approach, and ongoing continual improvement.

Source: Atos

It can also mean knowledge transfer about existing products from one manufacturing site to another by a facility change, a company merger, an acquisition, or a shift to a contract manufacturer (CMO).

Expertise required in tech transfer

Technology transfer requires a diverse set of expertise. Here are some of the key areas:

• Knowledge transfer
• Experience sharing
• Communications
• Inter and intra-company cooperation on a large scale.

EXPERT ADVICE

Document everything for a smooth tech transfer

In a recent episode of the PharmaSource podacast Bernardo Estupiñán shared his advice on how to manage a Tech Transfer. He explained that while CMOs will contractually need to agree to transfer any activity, they may not make it easy.

“There’s always a lot of resistance to tech transfers, especially if it’s external” say Bernardo, so make sure to get ahead of it.

“They will not want to have a technical person from the other CMO in their facility spilling their secrets! You don’t have somebody from Pepsi Cola coming and doing a transfer at Coca Cola!”

It is critical to make sure that your process and information is extremely robust, so that anybody could take it and adapt into the new facility without a problem. “Otherwise you will forced to spend time reinventing the processes again.” says Bernardo.

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How to manage a Tech Transfer

The success of technology transfer hinges on several elements, notably the foresight to identify potential risks and the strategic planning to address them. This ensures the team’s readiness to handle all scenarios, including unexpected occurrences.

It’s essential to integrate various facets of launch readiness – such as machinery, manpower, materials, manufacturability, measurement, market, and risk mitigation – through a thorough risk management process.

There are typically 3 main stages of a tech transfer. These are as follows:

Stage 1 : Defining and scoping

• Gathering knowledge to scope and establish the project’s organisation and charter
• Outlining program status and future outcomes
• Conducting gap analysis and failure modes as well as effect analysis risk assessment
• Identifying and covering long lead time items
• Defining the transfer protocol

Stage 2: Planning

• Developing a work breakdown structure and preliminary schedule
• Refining transfer protocols by respective parties
• Outlining critical milestones
• Gathering resource estimates
• Determining the most suitable course of transfer based on the outcome of risk assessment
• Assessing the robustness of scaling processes
• Developing risk management plans

Stage 3: Execution

• Tracking and managing the project by program team
• Collecting status data
• Analysing variances in operational data
• Identifying adaptive actions to assure quality and process optimization goals
• Reporting on project status to ensure transparency

Standardised Tech Transfer Procedures

Contract manufacturers have to be very flexible to accommodate various client needs, a standardised tech transfer procedure and common language are established to enhance the tech transfer process.

• Knowledge Transfer Package and Transfer Planning

The client should provide as detailed and complete knowledge transfer package as possible with product information 

 2. Detailed Assessment of the Product Technical Package

A detailed assessment of the technical package must be completed to understand the scale and equipment differences in the planning stage.

3. Analytical Method Transfers in the Early Stages of a Tech Transfer

Analytical methods are needed in the preliminary stages of a tech transfer as all the studies require certain testing to provide data and demonstrate the study results.

4. Regulatory Submission Preparation

Checklists are a great tool in helping to prepare regulatory submission packages by Regulatory Affairs and the functional teams.

5. Product Launch Preparation

The contract manufacturer should have a defined process for product launch so the team is ready for commercial supply to support the product launch.

How to accelerate the tech transfer?

Tech transfers in a highly regulated industry such as pharma can be a slow process. Here are strategies for how to accelerate time needed for a technology transfer while maintaining necessary quality.

• Digital Twin Strategy : A digital twin, a digital replica of the design space, allows companies to run a comprehensive set of virtual experiments. This enables a focused set of physical experiments to be chosen that efficiently utilise time and materials to fine-tune the design for optimum yield and quality assurance.
• Quality by Design (QbD) Framework : Following the QbD framework ensures that deep and detailed product and process knowledge is generated, evaluated, and documented throughout the whole product lifecycle.
• Dedicated Project Management Team : Establish a dedicated project management multidisciplinary team. This team will manage effectively and timely all communications between stakeholders.
• Standard Operating Procedures and Documents : Templated standard operating procedures and documents, approved by the quality team, will increase the speed, efficiency, effectiveness, and quality of technical transfer.
• Comprehensive Protocols : A comprehensive protocol coupled with carefully designed technical transfer protocols can enable a smooth technology transfer of your process.

Complexities of technology transfer

Common challenges for tech transfers include:

• Scope of Transfer : The complexity of technology transfer is determined by how much of a production chain is transferred. This could range from a single element (e.g., drug product fill and finish) to an entire process (from cell-bank manufacture to final drug product, with all the associated testing). The scope of transfer is a management decision with operational and strategic elements.
• Size of Transfer : The larger the scope, the more complex the transfer becomes. Complexity increases even more if different sections (e.g., drug substance, drug product, and analytics) are transferred from or to different sites.
• Multidisciplinary Activity : Technology transfer is a multidisciplinary activity involving diverse skills and competencies of participants, including project management, quality assurance/control (QA/QC), technical capabilities, engineering, manufacturing, and validation.
• Structural Reasons : In the biopharmaceutical industry, technology transfer is common for a number of structural reasons. These include the dichotomy between small, innovation-based drug companies and large ones able to conduct late-phase clinical development and endowed with manufacturing capacity; the high capital cost of biopharmaceutical plants, which makes contract manufacturing attractive; and the need for multiple scale-ups during a product’s life cycle.

Considerations when choosing a contract manufacturing partner

When seeking technology transfer support from a Contract Development and Manufacturing Organization (CDMO), it’s crucial to verify the CDMO’s track record and the strength of its project management and technical infrastructure.

This validation is key to ensuring the CDMO’s capability to comprehend and meet project specifications, manage potential risks, and deliver the project promptly and accurately on the first attempt.

Here are some areas to consider when planning to transfer to a contract manufacturer:

1. Geographic footprint

Gaining a comprehensive understanding of the market landscape goes beyond simply securing global manufacturing capacity as that is merely a tactical aspect. Your manufacturing partner should fully comprehend your campaign’s terrain and the broader landscape of your drug marketing strategy

2. Technology

The relevant technology surpasses the latest spray dryer or bioreactor. Your partner’s capabilities limit the potential of the equipment used. It is important to review your partner’s tech transfer performance against their ability to:

• Recognise and leverage economies of scale while prioritising safety and sustainability
• Deliver processing capabilities that are robust, reliable and validated, ensuring consistent and high-quality outcomes

3. Regulatory compliance

Evaluating a CDMO partner’s potential requires a thorough understanding of their ability to proactively maintain regulatory compliance. Consider the following key indicators:

• Dossier requirements and the capability to harmonise components for use in multiple markets
• Strong cGMP manufacturing operations with a demonstrated history of continuous improvement
• Effective documentation and filing data management with a focus on integrity • Regulatory responsiveness and efficiency in filing processes
• Established relationships with regulatory bodies and a comprehensive understanding of their requirements

4. Personnel

Having the right people involved is crucial for managing successful tech transfers between organisations. Look for external partners employing talented individuals with proficient project management and operational skills as well as scientific expertise.

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12 Critical Questions and Answers for a Successful Tech Transfer

February 10, 2021

Now, more than ever, companies are transferring products and processes from one site to another, often facing pressures on time, resources, and regulatory limitations. Why are technology transfers so difficult? What are the key factors for a timely and successful transfer? What is the right timing?

This blog covers the questions we have heard most frequently across more than 400 completed tech transfers. We’re sharing our collective experience and expertise to ensure your success in managing product and process transfers.

Why are technology transfers so difficult?

Effectively communicating thousands of details connected to the 75 key work packages across all areas of an organization for a process that is constantly changing requires extensive oversight and alignment. Any deviation can have consequences for the quality, efficacy, and safety of your product, and can result in regulatory submission delays.

What key information / process control measures need to be established early?

Quality systems including data integrity, identification of critical quality attributes, and critical process parameters are important to collect early in the process in documented form and will pay huge dividends throughout the product lifecycle.

How long does a technology transfer take?

There are several steps that typically help predict a transfer timeline:

• Site selection, when necessary, can take a few months up to a year. The timeframe is often dictated by the responsiveness of the receiving site and negotiations around related contracts.
• The technology transfer execution can take between 6 months to 2 years depending on equipment sourcing, the stability data that is required, and the efficiency of planning and issue resolution throughout the project.
• Finally, regulatory requirements must also be successfully met.

What is the right timing for a preclinical stage company to start preparing for regulatory considerations?

Typically, about a year before you are ready to enter the clinical phase, depending on the quality of the data you have generated so far. If you’re developing a complex biologic or gene/cell therapy, often companies need additional early-stage feedback two years or more before entering the clinic.

When transferring a product that is transitioning from Phase I to Phase II, what are the qualification requirements?

As you transition to Phase II, you need to look ahead and begin aligning to processes and requirements expected further down the lifecycle. When producing for Phase III, the process needs to be the same as for after launch. This means that the processes and methods need to have a control and validation strategy. Adequate documentation and justification should be built in up front, and generating material for Phase II needs to support with this strategy as well.

What are the unique considerations when transferring to single-use technology?

We have seen a shift away from single-use technology primarily because of the desire to go to continuous manufacturing, but also due to issues with single-use technology such as material shelf life, replacement time, inventory costs, disposal costs, environmental concerns, leaks, contamination, and employee exposure. The COVID-19 pandemic has exacerbated this effect with big shortages of disposables (flow kits, bags, filters, etc.) due to increased production of vaccines. These risks versus the high startup cost of multiple-use technology (e.g. cleaning strategy) need to be considered in advance.

What are some of the most important considerations when looking at a site to transfer to?

• We recommend looking at quality, compliance, capacity, customer service, and cost. Cost is the last consideration because the status of the other considerations will have a higher impact on overall cost than the cost per unit.
• Site selection is a balancing act of each of these parameters to find the best match for both your short-term and long-term goals.
• The key factor for a successful long-term partnership often resides in the customer service category, so remember to evaluate attributes such as communication and dependability.

How do you handle a transfer situation where there is little to no data from the sending site?

Often, there is more information available than is apparent at first. Many key documents are included in the regulatory submission, furthermore annual reports should be accessible for a sponsor, but leadership needs to be aligned on transfers and provide required support. “Man in the plant”, financial support, and other drivers may be needed to align long-term goals with short-term issues.

How do you handle a transfer when the sending and receiving site are not cooperative with each other or are having difficulty understanding one another?

• Change the paradigm. Identify the true leaders in an organization, understand the drivers and change the situation to align the needs of all parties involved. Meet often and make sure there are clear expectations (outcomes) using deliverables, timelines, etc.
• In some cases, another option is to partially redevelop and validate the manufacturing process and analytical methods at the receiving site, complemented with additional CMC testing to ascertain comparability of the products.

What are the most important raw material considerations for phase appropriate development and manufacturing?

• Like with site selection, we recommend looking at quality, compliance, capacity, customer service, and cost.
• It is important to realize that a large portion of issues during commercial manufacturing stem from the materials that are used. Therefore, in this stage thorough understanding of the material, its impurities, and/or potential for reactivity is critical for maintain a secure, steady supply.

What are the key success factors for a timely and successful technology transfer?

• Communication between sending and receiving site
• Availability of information for both the receiving site and sending site
• Availability of materials at the receiving site
• Executive leadership buy-in with documented, signed project charter
• Capability of the receiving site

What experience does ProPharma Group have in executing successful technical transfers?

• Number of product technology transfers managed: 423
• Combined number of years of technology transfer experience: 96
• Types of products transferred: Small Molecule, Large Molecule, OTC, ATMP, and Medical Device
• Transfer Stages Managed: Clinical to Production, Post-production
• Technology Transfer Resources We Utilize: 9 Gate Transfer Approach, 6 Gate Transfer Approach, Agile Methodology, PMI expertise, ISPE best practices

If you have a question we didn’t answer here, connect with our team and learn more about our solutions for successful and efficient tech transfers.

TAGS: Life Science Consulting

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Technology Transfer

Technology transfer and commercialization process.

Read about the Technology Transfer Process to see where your innovative efforts fit now and in the future. 

PRE-DISCLOSURE

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• Ex: it might take one-week to license a research material, as compared with one-year for a portfolio of pharmaceutical compounds.

Typically two licensing paths can be pursued when licensing technology.

Traditional License

Start-up company.

• Between the faculty member and the University
• Between the startup company and the University 

After the conflict-of-interest documents are signed, a representative from the Technology Transfer Office will begin to negotiate the license agreement. Please note that the University inventor is not permitted to participate in this process and is strongly encouraged to hire legal counsel to represent the newly formed business’ interests.

• Upfront license fee
• Industry standard royalty rates
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• Sublicense fees
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• A percentage of equity
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Technology Transfer Activities

DOI and its bureaus' technology transfer programs

What is Technology Transfer?

Technology transfer involves, first, developing new, or improving existing, technologies, and then spreading related information, knowledge, and expertise to the broader society in order to accelerate innovation to advance the Nation's economic, social and environmental well-being; and increase its economic competitiveness. It includes the process of increasing the availability of and access to tools, equipment, devices, objects, techniques, systems and methods of organization that embody such information, knowledge and expertise.

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Technology Transfer: Best Practices in Operational Development

Successful technology transfer depends on the ability to anticipate risks and plan ahead.

Successful technology transfer is essential to enable biopharmaceutical clients to safeguard supply, improve distribution, and reduce program costs and risks. When a customer approaches a contract development and manufacturing organization (CDMO) to gain technology transfer support, it is important to confirm that the CDMO has a proven history and a robust project management and technical platform in place. This helps ensure the ability to understand and execute against the project requirements, mitigate risks, deliver the project on time, and right first time. There are several key tools and best practices that enable the team to plan and deliver successful results, including mechanisms to overcome obstacles that may arise.   Table I provides a list of questions for a pharma company to ask a potential CDMO partner.

People and communication are key to project success

To ensure that the technology transfer is successful, the project leader will establish a cross-functional team comprising subject matter experts (SME) for each function. These functions should be matched at customer and CDMO locations where possible. It is important the team establishes a strong partnership and lines of communication such that key roles can work closely with their counterparts throughout the project. 

Establishing a communication plan and understanding each other’s escalation channels is crucial at the project start. Early in the project, reaching a level of trust and transparency can take time. To help, both companies must share all relevant details available, including product requirements, history, drivers, and any other information that will help understand one another’s needs. Project kick-off is best handled face to face as the team starts their relationship. It is important to have frequent face-to-face working sessions to allow the team to accomplish deliverables, especially if a significant obstacle arises.

As part of the communication plan, the teams must align on tools to manage the project and operate from a single ‘source of truth.’ This helps ensure alignment on expectations, timing of key deliverables, and communication between the organizations.

Project kick-off, and the conversations leading up to this point, represents a critical period where information sharing begins, and the project could suffer a delay if key information is missed at the start. A pre-defined checklist can assist the team in collecting all relevant information, as well as drive harmonization, incorporate lessons learned from previous projects, and proactively collect key data.

As timelines are often compressed, it may be tempting to jump into project activities immediately. Experience shows, however, that taking time to understand both companies’ requirements pays dividends, ensuring that important factors are not overlooked. For example, there may be differences in procedures for ordering equipment or materials, or shipping and receiving materials; change control processes; and document approval processes. As the project progresses, alignment will also be needed on validation strategy, and testing and inspection requirements. If this alignment does not occur early in the project, the timeline can be negatively impacted.

At the outset, the two teams should agree on a governance model, such as a steering team, which may be one tier of seniority above the project team. This team will monitor key project milestones and risks that may arise and take action on items escalated as requiring a decision. Additionally, a global technical forum can help connect global SMEs and functional leaders with the project teams quickly should technical issues arise. This model provides access to global resources and diverse perspectives, offering an additional level of technical oversight, decision making authority, and ability to mobilize resources as required to advance the project. The model also enables trends to be understood and learnings to be shared across the network.

The use of team huddles and visual boards is another tool to help drive understanding, accountability, and efficient decision making as the team executes the project. Visual boards are beneficial to represent the process, assign resources and action items, and flag issues. Huddles are key to efficiently aligning the team and functional management on project-related matters, as well as to recognizing the team’s accomplishments.

Proactive risk management and a ‘right-first-time’ mentality

The ultimate goal of technology transfer is to deliver the new medicine, at the highest quality, to the patients who need it, when they need it; therefore, the final process must be repeatable and well controlled. To minimize delays, the team must have a relentless focus on ‘right-first-time’ execution. Robust procedures, quality controls, and personnel training must be in place to enable the team to bring in each deliverable within the highest quality standards.  A right-first-time mentality is essential as part of the team’s culture. This begins with risk management to track, identify, and mitigate any potential risks, with a focus on ‘what could go wrong?’

Several risk management tools are available for technology transfer, such as formal assessments typically performed on the safety, quality, and overall process; others are part of the lifecycle validation process to identify, understand, and control the process. One major component of a successful risk management program is the use of a ‘risk register’ tool to document and track potential risks, requiring an action plan for each risk identified. 

A comprehensive launch readiness tool has proven key in identifying potential risks.  A risk management tool may include as many as 200 questions across the ‘seven Ms’ of machines, materials, manpower, manufacturability, market, measurement, and mitigation ( Figure 1 ). These questions examine what could go wrong and incorporate lessons learned from previous projects across the network. The tool is updated regularly throughout the project to help track any new risks that arise or are resolved. Each potential risk identified requires development of a mitigation plan with clear actions, timing, and owners. This tool is useful in keeping stakeholders and executive leadership updated throughout the project.

Stage-gate meetings (also known as milestone reviews) are necessary for the team to review relevant data, accomplishments, and risks. Typically, these meetings include steering team or company leadership representation, depending on expectations set at the project start. The stage-gate will determine whether the team is ready to proceed to the next phase of the project, or whether additional development work or process improvements are required.

As transferring a new process to the facility typically demands new equipment/technology, materials, and other requirements, the team should consider which aspects need particular attention. These may include a combination of additional hands-on training, clarity to batch record and procedure instructions, pre-execution readiness huddles, and additional on-the-floor technical support. It is important to share observations and learnings and ask for feedback from users of the new processes to ensure new requirements are well controlled. These controls must be incorporated into the final process.

Upon successful completion of the project, a final stage-gate meeting should be held to capture learnings and improvements prior to production turnover, including a ‘lessons learned’ meeting with participation from both companies. Learnings should be shared across the site and network and incorporated into future projects.

The technology transfer network should continuously evaluate the project management toolkit, helping optimize and enable successful technology transfers. This evaluation can be facilitated through a monthly forum and face-to-face workshops with the global technology transfer team. The team can pilot new initiatives and tools at their site before finalizing and standardizing across the network. Similarly, this global forum is key to leverage knowledge and resources to manage the overall project portfolio. 

Quality by design as an aid to technology transfer

In addition to a robust project management toolkit, for a technology transfer to be successful, the principles of quality by design (QbD) should be used to ensure a robust understanding of the process and design principles.

For large production batches to run smoothly, drug formulators need to be mindful of a compound’s performance, stability, and manufacturability from the earliest stages, and throughout formulation and process development. While drug product development scientists typically work on formulation development and stability improvement in Phases I and II of clinical trials, manufacturability is not always a priority. Scale-up, however, may not be straightforward or predictable if process knowledge that is scale-independent has not been developed. This knowledge should guide equipment selection, link the critical process parameters (CPPs) to critical quality attributes (CQAs), and establish the design space (DS). Sound scientific/engineering principles and mechanistic models should be employed whenever possible for scale-up of pharmaceutical unit operations. In addition, a robust risk assessment program invoking QbD principles at each stage of development is crucial for successful scale-up and transfer.

Process scale-up of pharmaceutical unit operations and understanding through models should be developed whenever possible. Models that describe pharmaceutical unit operations can generally be based on empirical, semi-empirical, and mechanistic approaches.

Predictive modeling

Models describing formulations and unit operations should be developed early in the process to avoid a trial-and-error approach. Formulation models are critical to understand the interplay between drug and excipients and provide a fundamental basis for rational formulation design in line with QbD principles. Figure 2 is a molecular dynamics model showing the effect of drug loading on a spray dry dispersion.

Mechanistic models for understanding the thermodynamics of unit operations (e.g., spray drying) are essential to predict the operating ranges a priori to running the actual process. Thermodynamic modeling of the process allows for the calculation of critical parameters and predictive performance. For scale-up and technology transfer, the CPPs are converted to scale-independent variables. Figure 3 shows an example of the design space (DS) for a spray dried product leading to particles of a desired morphology and size. Figure 4 shows a design of experiment (DoE) conducted for ‘compound X’ to identify the critical process parameters and critical quality attributes as part of process optimization and scale-up.

Effective implementation of models avoids reliance on a trial-and-error approach and provides critical information throughout drug product development. This leads to a robust manufacturing pathway and a thorough understanding to identify the CPPs and their impact on the CQAs. 

These examples demonstrate that having fundamental mechanistic models based on engineering principles in combination with targeted process DoEs result in critical process knowledge and understanding, which in turn supports scale-up and technology transfer.

Successful technology transfer depends on many factors, including the ability to anticipate risks and plan ahead, so that the team is prepared to deal with all possibilities, including unforeseen events. It is important to connect the dots across the various elements of launch readiness (e.g., machines, manpower, materials, manufacturability, measurement, market, and mitigation) through utilization of a comprehensive risk management process.

Tools such as a readiness checklist, stage gate, governance, and visual boards can be used to develop an in-depth understanding of the process upfront, day-to-day focus on project requirements, clear escalation channels, and controls in place to ensure progress into each phase of the project. QbD principles are used to ensure process understanding and knowledge aid in the scale-up and transfer from development to commercialization, with CQAs and CPPs that can be closely monitored and controlled.

Forming a partnership and communicating effectively and transparently between sending unit and receiving unit is key, as is promoting continuous improvement and learning.

Article Details

Pharmaceutical Technology Vol. 43, No. 4 April 2019 Pages: 54–58

When referring to this article, please cite it as D. Gallo and S. Konagurthu, "Technology Transfer: Best Practices in Operational Development," Pharmaceutical Technology 43 (4) 2019.

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Technology Transfer: Planning for Successful Technology Transfer

Anthony Grenier

In the pharmaceutical industry’s competitive and ever-changing business climate, companies are frequently divesting certain assets and acquiring others. As a result, the industry is often very busy with manufacturing site changes and drug product technology transfers. Technology transfer is also part of the manufacturing life cycle for drug products that companies outsource to contract manufacturing organizations (CMOs). However, while pharma companies systematically follow protocols and issue reports for drug product method transfer or validation, they often fail to take the time to issue a plan and report for technology transfer.

The International Society for Pharmaceutical Engineering (ISPE) technology transfer good practice guide 1 provides a thorough description of technology transfer documentation. In this article, I’ll provide practical information to help scientists or project managers who are new to technology transfer navigate the process and issue their first tech transfer plan. While my emphasis will be on solid oral dosage forms—particularly in the example plan I discuss later—the general approach and structure of a tech transfer plan is the same regardless of the dosage form. The four basic steps for documenting a technology transfer are shown in Figure 1. The steps begin with broad objectives and a high-level timeline and work toward a more detailed assessment and timeline.

Tech transfer charter/proposal 

The first documentation step is to prepare a tech transfer charter and tech transfer proposal, which are often combined into a single document. The purpose of the tech transfer charter/proposal is to provide a general framework for the tech transfer and detail its scope. This should also provide an understanding of the key driver(s) behind the transfer (such as cost savings, divesting a product, or changing the CMO that manufactures the product). 

It’s especially important to outline whether or not the sending and receiving units will collaborate on the transfer. I’m often exposed to projects where a drug product is currently being manufactured by one CMO, but the sponsor is qualifying a second CMO to make the product without the current CMO’s knowledge. This situation obviously brings an additional level of complexity to the tech transfer project and requires that the communications strategy be clearly laid out in the transfer documents. 

The charter/proposal should also include a description of the teams and stakeholders involved in the transfer as well as the process, including a high-level list of anticipated changes (such as sources of materials, equipment, and methods). The charter/proposal will also include the tech transfer’s success criteria, such as process validation performed by a deadline for launch in certain territories. 

Tech transfer package 

The tech transfer package should contain as much information as necessary to ensure that the receiving unit can successfully complete the transfer on time and within budget. This typically includes the documents listed in Figure 2. 

People sometimes confuse the package prepared as part of the request for proposal (RFP) with the tech transfer package. The package for RFP only needs to contain enough information for assessing the feasibility and estimating the costs of the transfer, whereas the tech transfer package is much more detailed. It is intended to consolidate all the product and process knowledge necessary for the receiving site to replicate the process in its own facility. 

If the sending unit or current CMO is not aware of the transfer, I recommend sharing a process flow diagram to the receiving unit rather than providing executed documents. Otherwise, I strongly recommend asking for authorization from the sending unit before sharing documents such as SOPs or manufacturing and packaging records. 

Risk identification and assessment 

Implementing a risk assessment strategy and mitigating those risks will bring a robustness to the transfer process and ultimately prepare it for validation. While I won’t go into the details of how to perform a risk assessment in this article, I will mention a couple aspects that are important when approaching risk for tech transfer.

First, the risk assessment will be part of the tech transfer plan and, like the tech transfer plan, is a live document. You will have approved an initial risk assessment at the beginning of the project, but both your knowledge and the risks will evolve as you deploy the transfer activities. Second, it’s very important that both the sending and receiving units contribute to the risk assessment. While you can identify the risks based on a review of the documents, you should also ensure that subject matter experts from both the sending and receiving units meet to discuss them. 

Tech transfer plan 

As previously mentioned, the tech transfer plan content is similar to that of the tech transfer charter/proposal, but the items are addressed in greater detail. The ISPE good practice guide states that a tech transfer plan should include the following: 

• Scope and objective 
• Resources and budget 
• Timeline and milestone dates 
• Roles and responsibilities 
• Deliverables and acceptance criteria 
• Assumptions, constraints, and risks 
• Detailed risk mitigation plan to address items identified in the gap analysis 
• Work plan and goals for the tech transfer process 
• Work plan and goals for development studies at either the receiving unit or the sending unit 
• Equipment details
• Any demonstration studies required 
• Supply-chain and cold-chain logistics, if applicable 
• Training requirements 

At this stage, the initial project team should also include the subject matter experts and ad hoc personnel required at both the sending and receiving units to successfully conduct the transfer. Next steps 

Once the tech transfer plan is in place, the next steps are to: 

1. Execute the transfer 

Execution usually starts with transferring or ordering materials, analytical supplies, and equipment/parts, followed by analytical method transfer or validation and lab-scale or process scale-up studies, if required. 

2. Qualify the process 

Process qualification usually corresponds to the validation of the processes and the manufacture of the first marketable units. 

3. Finalize the transfer 

Once you’ve validated the manufacturing and packaging processes and have the approved validation report, the final step is to wrap up the tech transfer documents with a tech transfer report. The tech transfer report will assess if the transfer has successfully adhered to the timeline and budget and whether the technology at the receiving unit has performed as expected. For example, if there was an unplanned need to change specifications or use a different grade of raw materials, you should list it in the tech transfer report. Most importantly, the tech transfer report should include a section with lessons learned. This section should compile the receiving unit’s debrief notes to recognize the team’s challenges, achievements, and efforts. 

Example tech transfer plan 

Let’s look at an example tech transfer project in which a client of mine decided to transfer a well-recognized OTC brand from a long-term CMO to a new CMO. 

1. Purpose and scope 

In this section, we discussed the drivers for the transfer and indicated the receiving CMO. In this case, the main drivers for the change were costs and a risk that the current CMO might go out of business due to a lack of investment in its aging facility.

The scope included what needed to be transferred (process, analytical, packaging, and equipment), any anticipated major changes or need for development, and markets where the products would ship. 

2. Product and process overview 

Product description. We detailed the qualitative and quantitative registered formula for the product, which was a chewable tablet. We provided the claim/tab, international units, any overage, quantity per tablet, and percentage formula for each medicinal and non-medicinal ingredient. 

Process overview. We listed all process steps and equipment from the sending site. We also included a flow diagram, which is ideal. 

Packaging overview. We listed all the packaging SKUs and mentioned any that were discontinued.

3. Transfer team responsibilities 

In this case, the sending unit was not included, because the tech transfer wasn’t collaborative between the two sites. We listed the following groups: technical development and process; quality assurance; quality control; manufacturing; engineering; and health, safety, and environment. We also included the representatives assigned for each group, and they formed the core team. 

4. Documents and information to be transferred 

We provided the receiving unit with the documents listed in Figure 2. In our case, it was a straightforward process using an active ingredient made specifically for the company and with a history of sticking during compression. We made sure to include a CofA and specifications from the active ingredient supplier (including the supplier item number) as well as the active ingredient characterization report (the supplier provided a specific particle size distribution). Because the active ingredient had a history of sticking issues, we made sure to include in the package not only the drawings of the tooling but also a copy of the order to the tooling manufacturer so that the receiving unit would know which coating or treatment was applied. (Don’t assume that the tooling supplier will remain the same; it may change.) 

5. Side-by-side comparison and risk assessment 

A side-by-side comparison, as shown in Figure 3, is a good way to visually compare the process at the sending unit with the proposed process at the receiving unit. Following the gap analysis and identification of risks from the potential and proposed changes between the sending and receiving units, we provided an initial risk assessment, as shown in Table 1. 

6. Planned transfer activities 

Pilot batches. The company decided to perform a functionality characterization of the active ingredient and critical excipients, which involved manufacturing several small pilot batches to confirm the feasibility of compressing the product using the active and excipients that the receiving unit would be using. This step was essential because the product was a direct-compression tablet. 

We performed a first screening of the different active ingredient suppliers by testing different lots for chemical and physical characteristics (bulk and tapped density, particle size analysis, and flow properties). The technical group summarized these trials in a technical report, which should also document changes made to the compression tooling, if any. 

Stability batch. Based on the recommendations of the technical report, the company manufactured a stability batch, still at pilot scale, and issued a manufacturing/ packaging protocol and batch reports as well as a stability protocol. 

Scale-up. As part of the transfer to the commercial-scale equipment, we evaluated and confirmed the critical process parameters and implemented in-process testing/controls during the stability batch. We issued a protocol and batch reports, which then served as a reference for the process validation documents. We also used the tablets generated at this stage to assess the packaging tooling prior to qualification and determine whether a new tooling or packaging configuration was required. 

Other studies. We also performed a process validation, cleaning verification/validation, bulk holding time, and packaging validation studies. 

7. Conclusions 

In this case, we concluded that changing the active ingredient supplier will justify performing and budgeting for pilot batches and pre-market stability studies. These lots would also allow the receiving site to confirm that the sticking issue was not present at pilot scale, though it would still need to be monitored at larger scale. 

8. Attachments

This section includes any attachments used to prepare the tech transfer plan. In this case, we included formal documents such as process validation reports from the sending site along with meeting minutes for key project decisions and the initial risk assessment.

Conclusion 

A tech transfer plan is a living document that captures all activities, changes, and risks involved with a technology transfer. It should not be something that you generate at the beginning of a transfer process and then forget, but rather a valuable tool that the project manager or technical lead maintains from the project inception up to the completion of all activities. Following the disciplined approach I’ve described in this article can help pharmaceutical companies and CMOs increase the success rate of future technology transfer projects. 

References 

1. ISPE, Good Practice Guide: Technology Transfer, Third Edition (2018). https://ispe.org/publications/guidancedocuments/good-practice-guide-technology-transfer- 3rd-edition. 

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This interest group has as its main objective to capture the opportunity given by the benchmarking of our experience in Technology Transfer projects; with potential opportunity like TR, articles, position papers, training sections, and lectures.

The group will discuss the technology transfer projects topics, from manufacturing process to analytical transfer, from equipment user requirements definition to process validation, from Contract Manufacturing Organization selection to Business Discontinuity, from appropriateness of the documentation to lesson learnt approach and statistical data analysis, without  never forget the ethic behind our job.

Pharmaceutical Technology Transfer Projects consist of planned and controlled actions that are based on well-defined acceptance criteria to convey a Pharma technology with all its attributes from a sending unit to a receiving unit and involve a complex group of internal and external stakeholders. Risks are hidden everywhere; it’s mandatory to have a robust and efficient methodology to identify, mitigate and control them.

For that reason we think a Technology Transfer Interest Group will help all of us find best practices, monitor worldwide trends, analyze clusters of peculiarities based on companies, countries, dosage forms, drug entities.

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University of Bremen as a Pioneer: 30 Million Euros for the First Center for Accelerated Technology Transfer

The three pilot projects at the University of Bremen will pave the way for a resource-saving future. The first of these projects aims to accelerate the production of zinc-ion batteries, which play a decisive role in the expansion of solar and wind energy. The batteries are a safer, cheaper, and more environmentally friendly alternative to lithium-ion batteries, as they are based on readily available raw materials in an aqueous solution.

The second project aims to produce proteins for sustainable feed in aquaculture. They are essential in order to replace fishmeal and thus reduce overfishing. No fossil raw materials are needed, as the single-cell proteins are produced by microbial electrosynthesis using electricity, carbon dioxide, and wastewater.

The third project focuses on developing new types of sensors. These ensure the safe storage and reliable transportation of hydrogen, which is a key factor for climate-friendly mobility and the energy revolution. Based on organic semiconductors, the highly sensitive sensors allow for a particularly fast detection of leaks and micro fissures.

Eighteen applications were submitted from eleven Federal States. With the “MaTeNa innovate! Center” at the University of Bremen, the Joachim Herz Foundation aims to establish pioneering knowledge and technology transfer structures and close the systemic gap in innovation chains. MaTeNa stands for Materials – Technologies – Sustainability (German “Nachhaltigkeit”). The successful application was submitted by MAPEX – Center for Materials and Processes, which bundles activities in the Materials Science and Technologies high-profile area at the University of Bremen.

Flagship Project for the Transfer of Innovative Research Findings

Kathrin Moosdorf, Senator for Environment, Climate, and Science, said: "The University of Bremen conducts research for the benefit of society. Scientists here are already finding practical solutions - often in collaboration with companies - for the key challenges of our time and our everyday lives. This is knowledge transfer at its best. The funding awarded by the Joachim Herz Foundation is a great endorsement of this work over the past few years. The new 'MaTeNa innovate! Center' encourages us and the university to continue on this path and allows for even more innovation in Bremen."

Professor Michal Kucera, Vice President for Research and Transfer at the University of Bremen: “The MaTeNa innovate! Center bundles the innovative power of the outstanding materials research at the University of Bremen and our partner institutions in their search for new materials and production processes for the sustainable development of our society. This will enable us to transfer innovative research findings into new solutions for mobility, energy storage, and the circular economy much faster. As a flagship project for Northern Germany, MaTeNa underscores the vision of the Joachim Herz Foundation and the guiding principle of the University of Bremen: We want to assume social responsibility and actively shape a sustainable future through accelerated knowledge and technology transfer.”

“Innovative materials and their processes play a key role in the search for sustainable solutions to technological challenges,” states Professor Kurosch Rezwan, head of the MaTeNa innovate! Center and spokesperson of the MAPEX – Center for Materials and Processes at the University of Bremen. “I am therefore extremely delighted about this significant success: The MaTeNa innovate! Center enables a faster transition of the outstanding basic research of MAPEX into application through tailor-made transfer projects.”

“This is the biggest success for MAPEX to date,” comments Dr. Hanna Lührs, MAPEX Science Manager, “The innovation challenges are truly unique, as they allow us to take up current issues from industry and work together on innovative solutions.”

Professor Sabine Kunst, chair of the Joachim Herz Foundation: “We want to offer outstanding researchers an ideal environment where they can put their research findings to practical use for society and the economy. The University of Bremen impressed our jury with research projects that address present-day problems. Moreover, their proposal provided a convincing blueprint for how a systemic transfer to the economy can be created that benefits us all. I am convinced that together we will be able to attract attention beyond Bremen with the MaTeNa innovate! Center.”

As of 2026, in addition to the three pilot projects, the MaTeNa innovate! Center wants to support further pioneering projects from MAPEX and thus consolidate its role as a driving force for innovation. Scarcity of resources in materials and energy is also at the heart of the “The Martian Mindset: A Scarcity-Driven Engineering Paradigm” Cluster of Excellence proposal initiated by MAPEX. It was invited by the German Research Foundation to submit a full proposal and offers additional potential for technology transfer projects at the MaTeNa innovate! Center.

Further Information

www.joachim-herz-stiftung.de/en/research/research-and-application/joachim-herz-transfer-center

www.uni-bremen.de/en/mapex

uni-bremen.de/en

Dr. Hanna Lührs and Professor Kurosch Rezwan MAPEX Center for Materials and Processes University of Bremen Phone: +49 421 218-64580 Email: [email protected]

Embracing the AI-Energy-Climate Nexus

Resolving the contradiction between AI’s thirst for electricity and its potential to reduce emissions will require technology and energy firms to cooperate in new and creative ways. The “Change Makers Majlis” in Abu Dhabi in November offers an opportunity to discuss what that could look like in practice.

ABU DHABI – Six months ago, at the United Nations Climate Change Conference in Dubai (COP28), the world transcended geopolitical divides – something few believed possible – and united behind a realistic plan, known as the UAE Consensus , to promote sustainable prosperity and address the threat of climate change. Nearly 200 governments and all sectors of the global economy coalesced around a practical, science-based pathway for achieving low-carbon economic growth while keeping 1.5° Celsius within reach.

The key to the agreement’s success was inclusivity : no one was excluded, no industry was sidelined, and no solution was off the table. As we move to implementation, the world must leave no stone unturned to accelerate progress. Specifically, that means embracing artificial intelligence, which promises to have a far-reaching, transformational impact on the energy transition and is projected to add $7 trillion to global GDP over the next ten years.

It is difficult to overstate the potential of AI in the fight against climate change. This evolving technology can change the pace of progress by redesigning industrial processes, optimizing transport systems, maximizing energy efficiency, and minimizing emissions at scale. AI will also strengthen our adaptive resilience through innovations in agriculture, water security, and health.

But AI development will necessarily lead to a surge in energy demand. Resolving the contradiction between AI’s thirst for electricity and its potential to reduce emissions will require technology and energy firms to cooperate in new and creative ways.

There are grounds for optimism. AI is already driving efficiency gains across industries. Through AIQ , its technology joint venture with G42 and Presight, ADNOC has used predictive maintenance and machine-learning tools to reduce carbon dioxide emissions by up to a million tons in just one year. Other power companies are using neural networks to mitigate the intermittency and storage challenges of renewable energy by forecasting weather patterns and preempting peaks and dips in usage.

In material sciences, researchers are using AI to identify the molecular structures best suited for carbon capture. The technology is also transforming agriculture , another energy-intensive sector, by analyzing micronutrients, enhancing crop yields, and minimizing water use by as much as 40%. Over the next five to ten years, AI is expected to enable breakthroughs in fusion, hydrogen, and modular nuclear power, long-term battery storage, and as-yet-unimagined climate solutions.

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The flipside to AI’s transformative potential is its insatiable energy consumption, which is putting additional stress on an already-stretched power system. Since 2019, emissions from the largest AI firms have increased by roughly 30%. By 2030, demand for data-center power worldwide is expected to grow by 160% , owing to the technology’s vast processing needs, and these new operations could consume as much electricity as Canada , implying a doubling of carbon dioxide emissions. Bridging this gap will be difficult, as no single energy source is currently capable of meeting such a huge leap in demand.

Major tech companies are starting to collaborate with energy companies to face this challenge head-on. In May, Microsoft and Brookfield closed a deal to develop 10.5 gigawatts  of renewable capacity by 2030. Masdar, the United Arab Emirates’ leading renewable-energy company, is on track to quadruple its capacity to 100 gigawatts by 2030 and is exploring opportunities to supply the tech sector with clean electricity. There is also increased investment in nuclear-powered data centers, although these will take decades to build. In the interim, up to 200 billion cubic meters of natural gas – the least carbon-intensive fossil fuel – per year will be needed, as will significant investment in global grid infrastructure to cope with increased demand.

Adopting a holistic approach is critical to addressing these problems and reaping AI’s potential benefits. To that end, I am convening a “ Change Makers Majlis ” – a majlis being a traditional gathering that encourages the exchange of diverse perspectives – in Abu Dhabi in November to discuss AI and the energy transition. Business leaders from the energy and technology sectors, policymakers, investors, and civil-society organizations will come together to reimagine the relationship between energy, AI, and inclusive economic growth.

The UAE has an established track record as a responsible energy supplier. Given our commitment to sustainable development, and our emergence as an AI leader – with investment platforms like MGX , infrastructure developers like G42, and the region’s largest and fastest-growing large language model, Falcon – we are keen to bring all relevant stakeholders together on an issue of profound importance to all humanity. By building a bridge between energy and AI, we can help realize the UAE Consensus and, in doing so, take advantage of the greatest economic opportunity since the First Industrial Revolution.

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The US president’s disastrous performance in the first – and possibly only – debate with Donald Trump reinforced an already-entrenched narrative that will be difficult, if not impossible, to alter. His performance could even threaten to turn him into something of a lame duck, further weakening his influence at home and abroad.

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10 Institutions Selected for Grant-funded Technology Partnerships to Improve Transfer Experience for College Students

June 25, 2024

BOULDER, Colo. – Ten accredited postsecondary institutions in the West have been selected to participate in an innovative partnership project that aims to improve outcomes for transfer students by leveraging campus technology.

The Technology and Partnerships for Transfer Success project, administered by the Western Interstate Commission for Higher Education (WICHE), is pairing a four-year university or university system with a two-year college or technical school in unique partnerships. Staff from each school (including but not limited to academic advisors, registrars, and information technology professionals) will work together on piloting technological solutions to improve pathways for students transferring between the two postsecondary institutions.

The partnerships are:

• SOUTH DAKOTA: Dakota State University and Lake Area Technical College are implementing course equivalency software to support transfer in high-demand workforce areas for students with technical degrees.
• MONTANA: Montana University System and Helena College are piloting applications to increase visibility and transparency of degree plan options and requirements to students and advisors with the goal of having them implemented across the system.
• ARIZONA: Northern Arizona University and Maricopa Community College District are developing a technology platform to exchange critical student data to better enable staff from both institutions to identify and support “some college no credential” students in re-enrolling and completing their credential.
• ARIZONA: University of Arizona and Pima Community College are implementing “UnBlockEd,” a boutique portal that seeks to support students with complex academic histories.
• COLORADO/WYOMING: University of Northern Colorado and Laramie County Community College are implementing student-facing technology to increase transparency around transfer outcomes.

This project is an outgrowth of WICHE’s commitment to student access and success by building upon the foundational work from its decade-long Interstate Passport initiative to create seamless transfer pathways for college students.

“The complexities of transfer remain a perennial issue. Students need flexible on-and-off-ramp opportunities for postsecondary education, while institutions need to ensure quality and be able to operate at scale,” said Ray Burgman Gallegos, vice president, Programs and Services, at WICHE. “This project was developed as a response to the need for innovation, improvement, and the removal of impediments to successful and seamless student transfer, particularly technological advancements that address information gaps for students and academic advisors.”

The two-year project is funded by an anonymous grant. Each institutional pairing will receive up to $30,000 for their specified technology development; the 10 selected universities and community colleges will also participate in a community of practice facilitated by WICHE to exchange information about the technology improvement and costs; share prototypes, testing and tracking results; and collect and share insights into successful approaches to student support and curriculum mapping for other postsecondary institutions.

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IGNIITE 2024 Selectees

ARPA-E announced approximately $11.5 million in funding through its new Inspiring Generations of New Innovators to Impact Technologies in Energy 2024 (IGNIITE 2024) program focused on early-career scientists and engineers converting disruptive ideas into impactful energy technologies. Each IGNIITE 2024 awardee will receive approximately $500,000 to advance research projects at universities, national laboratories, and in the private sector that will span the full spectrum of energy applications, including advanced energy storage systems, fusion reactor technology, carbon-negative concrete alternatives, power electronics for grid reliability, critical material recovery, energy-efficient water desalination, plastic depolymerization, and more. Read more in the press release here . 

The following individuals selected through IGNIITE 2024 are:

University of California, Berkeley – Berkeley, CA

Jessica Boles is an assistant professor in electrical engineering at the University of California, Berkeley, and co-director of the recently launched Berkeley Power and Energy Center. Boles will explore a new class of power electronics based on modular piezoelectric components, which are capable of enabling order-of-magnitude scale miniaturization and significant gains in efficiency for power electronics in a wide variety of applications.

Project: High-Performance, Modular Piezoelectric Components for Miniaturized Power Conversion – Award Amount: $500,000    

Syracuse University – Syracuse, NY

Craig Cahillane is an assistant professor at Syracuse University with a background in gravitational wave detection. In this project, Cahillane will build a novel prototype for neutral beam injection in fusion reactors. The work will support the development of electricity generation and storage for enabling fusion power generation and new advancements in lasers and materials technologies.

Project: Ultra-High Power Photoneutralization Cavity for Neutral Beam Injection in Fusion Reactors – Award Amount: $500,000 

Duke University – Durham, NC

Liang Feng is an assistant professor at Duke University in mechanical engineering and materials science. Feng is developing a process to convert plastic waste, such as plastic bottles and bags, into adsorbents to capture carbon dioxide. The approach seeks to take advantage of the tough and long-lasting nature of plastics to create carbon-dioxide sponges with high porosity and durability.  

Project: Upgrading Plastic Waste into Low-Cost Porous Adsorbents for Direct Air Capture – Award Amount: $500,000 

Rensselaer Polytechnic Institute – Troy, NY

Fudong Han currently holds the Priti and Mukesh Chatter ’82 Career Development Chair Assistant Professorship at Rensselaer Polytechnic Institute. Han aims to develop a low-cost solid-state battery that enables cleaner, safer, and more efficient electric aircraft. This project leverages Han’s recent discovery utilizing halide-based solid electrolytes.

Project: Critical Metal-Free, Conversion-Type Solid-State Batteries for Advanced Air Mobility – Award Amount: $500,000   

National Renewable Energy Laboratory – Golden, CO

Nelson James is a researcher in the National Renewable Energy Laboratory’s advanced building equipment research group. James will develop a proof-of-concept prototype of a multifunctional heat pump to reduce building heating and cooling emissions and improve building energy resilience. This will be accomplished through new compression approaches and system designs.

Project: Electrochemically Looping Adsorptive Heat Pumps for Next-Generation Building Decarbonization – Award Amount: $499,922

Katrina (Kat) Knauer is a researcher at the National Renewable Energy Laboratory, the CTO of the BOTTLE Consortium, and an assistant adjoint professor at the University of Colorado, Boulder. Knauer will focus on a new process for mixed, variable bio-based polyester waste streams based on a volatile amine catalyzed methanolysis process. This technology will reduce reliance on both fossil fuels and agricultural feedstocks.

Project: Mixed Polyester Deconstruction & Monomer Recovery to Enable a Circular Bioeconomy – Award Amount: $499,999

University of Wisconsin–Madison – Madison, WI

Sebastian Kube is an assistant professor in materials science and engineering at the University of Wisconsin–Madison. The objective of Kube’s project is to build an autonomous laboratory platform, “AlloyBot,” which will develop new structural alloys for energy and propulsion technologies. AlloyBot will synthesize and test 100 new alloy compositions per week with minimal human assistance.

Project: AlloyBot: Autonomous Platform to Develop Alloys for Energy and Propulsion Technologies 100x Faster – Award Amount: $500,000 

Michigan State University – East Lansing, MI

Woongkul Lee is an assistant professor in electrical and computer engineering at Michigan State University. The objective of Lee’s research is to develop an optically powered ultra-high-speed wound-field synchronous generator for uncrewed aircraft. The generator will be integrated with an optical encoder for position estimation to maximize its power density, reliability, and power handling capability.

Project: Optically Powered Ultra-high-Speed (OPUS) Wound-Field Synchronous Generators – Award Amount: $500,000 

Jinxing Li is an assistant professor in the Department of Biomedical Engineering and the Institute for Quantitative Health Science and Engineering at Michigan State University. In this project, Li aims to reduce carbon emissions associated with both building materials and construction methods through 3D robotic bioprinting of biogenic concrete structures to create next-generation sustainable and intelligent buildings.

Project: Robotic 3D Bioprinting of Entire Building Structures Using Biogenic Concrete – Award Amount: $500,000 

Peregrine Hydrogen – Santa Cruz, CA

Rain (Ruperto) Mariano is Director of Cell Development at Peregrine Hydrogen, focused on delivering green hydrogen without the premium. Mariano’s objective is to develop an electrolysis technology to provide affordable hydrogen by cutting the energy intensity of water electrolysis in half. If successful, the technology has the potential to decarbonize highly polluting hydrogen used in industry today by providing a cost-competitive alternative.

Project: Advanced Electrolysis Architectures for Low-Cost Green Hydrogen – Award Amount: $500,000  

Luca Mastropasqua is an assistant professor in mechanical engineering at the University of Wisconsin-Madison. Mastropasqua seeks to transform the waste plastic upcycling process by studying, developing, and characterizing an innovative solid-state electrochemical membrane reactor and its thermal integration. This will be achieved through high-temperature electrochemical hydrogenative depolymerization of long amorphous and semi-crystalline polymers.

Project: Direct High-Temperature Electrochemical Hydrogenative Depolymerization for Waste Plastic Upcycling – Award Amount: $500,000 

Paul Meyer is a researcher at the National Renewable Energy Laboratory. In this project, Meyer seeks to develop a lignin-based concrete alternative for buildings and construction to address major challenges facing this industrial sector. The project will explore different types of lignin, the effects on chemical reactions and drying times, and pathways to large-scale commercialization.

Project: BUILD’EM: Chemistry, Performance, and Path to Market of a Cement-less Construction Material – Award Amount: $499,989   

Lawrence Berkeley National Laboratory – Berkeley, CA

Justin Panich leads a research group at Lawrence Berkeley National Laboratory and is a deputy director at the Joint BioEnergy Institute. In this project, Panich will develop a bioelectrocatalytic cell that converts renewable energy, carbon dioxide, and nitrogen gas into ammonia. The team will maximize microbes for ammonia production through bioengineering strategies and integrate the microbes into an electrolysis-coupled growth chamber.

Project: Carbon-Negative and Ambient Production of Fertilizer Precursor – Award Amount: $497,151 

Lydia Rachbauer is a scientist in biological systems and engineering at Lawrence Berkeley National Laboratory. Rachbauer aims to develop a scalable and sustainable carbon conversion process to minimize greenhouse gas emissions in the aviation sector. The approach leverages the microbial conversion of waste-derived syngas into the C6-carboxylic acid caproate as a precursor for sustainable aviation fuels.

Project: C1 Bioconversion Platform: Integrating Acetogenic Consortia for Circular Economy Solutions in Sustainable Fuel Production, Industrial Efficiency, and Decarbonization – Award Amount: $499,501

University of Washington – Seattle, WA

Julie Rorrer is an assistant professor of chemical engineering at the University of Washington. In this project, Rorrer will harness plastic waste to produce liquid organic hydrogen carriers, addressing plastic pollution and hydrogen storage needs simultaneously. The process uses an adaptive catalytic reactor that converts various plastic wastes using different modes depending on the availability of hydrogen.

Project: Development of an Adaptive Catalytic Reactor to Store Intermittent Green Hydrogen Using Plastic Waste – Award Amount: $500,000

ChemFinity Technologies – Brooklyn, NY

Adam Uliana is the co-founder and CEO of ChemFinity Technologies, a cleantech startup in Brooklyn, NY, that spun out of University of California, Berkeley in 2022. Uliana is developing new processes to recycle critical minerals by leveraging ChemFinity’s porous sorbent material technology. The approach selectively recovers many critical minerals from wastes, including e-waste, spent catalytic converters, and other sources.

Project: Tunable Porous Polymer Networks with Unprecedented Efficiency in Recovering Critical Metals – Award Amount: $500,000

University of Alabama – Tuscaloosa, AL

Zhongyang Wang is an assistant professor in chemical and biological engineering at the University of Alabama. Wang will use sodium borohydride as a liquid fuel for a direct borohydride fuel cell to empower marine vessels. Sodium borohydride is readily transportable using existing infrastructure, and no greenhouse gases would be generated during the operation of the liquid-liquid fuel cell.

Project: Tailoring Bipolar Membrane Interfaces to Boost Direct Borohydride Fuel Cell Performance for Marine Transportation Applications – Award Amount: $499,803 

University of California-Irvine – Irvine, CA

Xizheng (Zoe) Wang is an assistant professor in mechanical and aerospace engineering at the University of California, Irvine. Wang will investigate a better method to produce multi-elemental nanodisks to enable scalable clean hydrogen production. The electrified vapor deposition method will produce nanodisks that can reduce or eliminate the usage of precious metals for a more robust and sustainable supply chain.

Project: High-Entropy Nanodisks by Ultrafast Electrified Vapor Deposition for Hydrogen Production – Award Amount: $500,000 

University of Nebraska-Lincoln – Lincoln, NE

Jun Wang is an assistant professor in electrical and computer engineering at the University of Nebraska-Lincoln. Wang is developing solutions to enhance power grid resilience through a first-of-its-kind 10-kilovolt high-frequency press-pack silicon-carbide MOSFET module. The module will have 30 times faster switching frequency and 5 times higher power density than the state of the art.

Project: Multicell Electrical-Transient-Accelerated Press-Pack Modules (METAPAK) – Award Amount: $500,000 

Oak Ridge National Laboratory – Oak Ridge, TN

Andrew Westover is a staff scientist at Oak Ridge National Laboratory with a focus on solid-state batteries. Westover’s project will develop bulk ionic glasses (BIG) using traditional glass processing that captures the desirable ductility of LiPON glass. The ultimate project goal is demonstrating lithium-metal anode charging/discharging using a BIG electrolyte separator, a traditional cathode, and a Li metal anode.

Project: Ductile Bulk Ionic Glasses for Electric Vehicle Batteries (BIGBATT) – Award Amount: $500,000 

Battelle Energy Alliance (Idaho National Laboratory) – Idaho Falls, ID

Michael Woods is a research scientist at Idaho National Laboratory with over ten years of experience in molten salt experimentation. Woods’ project will investigate the use of brazing for joining salt-facing materials for molten salt energy technologies, including nuclear molten salt reactors and thermal energy storage systems.

Project: Performance of Brazed Materials for Molten Salt Energy Technologies – Award Amount: $500,000 

Guang Yang is a member of the energy storage and conversion group at Oak Ridge National Laboratory. Yang is working to revolutionize energy storage by creating a groundbreaking battery that uses low-cost materials like sodium and carbon dioxide. The battery could be up to 40 times more powerful and 90% cheaper than current technologies.

Project: Supercritical Carbon Dioxide-Leveraged Redox Flow Batteries (SUPERCOOL-RFB) – Award Amount: $500,000 

University of California, Santa Barbara – Santa Barbara, CA

Yangying Zhu is an assistant professor in mechanical engineering at the University of California, Santa Barbara. Zhu will develop a desalination system using solar thermal energy and multi-stage distillation. The work will enhance thermal transport processes to utilize energy more efficiently, which can significantly reduce energy consumption compared to existing industrial desalination processes.

Project: Solar Thermal Membrane Desalination via Thin-film Phase Change – Award Amount: $500,000 

Funding opportunity: 1962: Accelerated knowledge transfer three (AKT3) 2024

See the  full opportunity details on the Innovation Funding Service .

UK registered academic institutions, research technology organisations (RTO) or Catapults can apply for a share of up to £1 million to fund innovation projects with businesses and not for profit organisations.

Eligibility summary

Projects must be led by a UK registered higher education or further education institution, RTO or Catapult collaborating with UK registered businesses and not for profit organisations with four or more full time equivalent employees.

Projects must deliver targeted interventions to accelerate the evaluation or development of an innovation project or concept.

Business must contribute a minimum of 10% of total project costs.

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