Technology Transfer Series
Knowledge Transfer: Not a Time to Be Coy
Knowledge Transfer: Not a Time to Be Coy
Tech transfer is not simply moving a product from one organization to another. It is transferring the full depth of knowledge that underpins how that product is made. This is where the real challenge lies. Batch records, methods, material specifications, and equipment lists are essential, but they don’t necessarily capture everything that is needed.
There’s More to the Story
Just as important as formal documentation is the sponsor’s tribal knowledge–critical information and know-how that is essential for successful process and product transfer. Tribal knowledge is based on a combination of experience, intuition, and practical insights from individuals who have worked extensively with the product. This knowledge fills gaps that official documents do not cover. How were parameters chosen? Which risks were explored or ruled out? What had to be adjusted during development? These details explain how the process evolved.
Too often, formal documentation is solely relied upon, and the new CDMO must rediscover details on their own. For example, transferred analytical test methods often only outline basic process steps. What can be missing is nuance, an important factor in the method.
When we receive a method that states, “mix until dissolved,” it’s difficult to understand what is required to get the sample into solution. Is a simple stir bar sufficient, or is something more specific like inversion, vortex, or sonication needed? This detail can make or break our ability to deliver expected results for the transferred method.
The Information Sweet Spot
The quality and completeness of documentation is critical, and too little information forces the receiving team to make assumptions or do duplicate work. Conversely, too much detail, especially if it is not well-organized, leads to time lost sifting through documents to find the proverbial ‘needle in the haystack’. It can also force reviewers who are less familiar with the program to judge the relevance of vital details versus extraneous information.
Essential elements, which sponsors are sometimes surprised to find out are needed, are a target product profile (TPP) and the product’s critical quality attributes (CQAs). To transfer a product, a CDMO needs to complete risk assessments based on this information. Risks can be very different when comparing something like acceptable particulate levels in a product that is administered via subcutaneous injection vs. an ophthalmic treatment that is injected into the eye. Therefore, these details are a critical part of the documentation.
Also, documents that are written too prescriptively may limit the flexibility needed to adapt a process to a new environment, a common problem in tech transfer. (Keep an eye out for a future post where we dig into the details on this issue.)
It’s common for different manufacturers to use distinct terms for the same thing. Ensuring alignment on terminology is a basic but critical step to ensuring that all parties have a shared understanding of the information.
The Former Party’s Part
When a product is being transferred, getting as much detail as possible directly from the former manufacturer is ideal. This is generally more straightforward if the sponsor is transferring from their own site. However, it can be cumbersome if a product is being transferred away from a manufacturer that was formerly under contract.
Directly involving the original process experts, though sometimes difficult, greatly benefits technical discussions. Reverting back to the idea of tribal knowledge, a former service provider may have more expertise in a product’s development and manufacturing processes than a sponsor. While not always possible, if the sponsor can serve as a mediator to guide the discussions with the former service provider, valuable details will emerge.
In one project transferred to Lifecore, the sponsor contracted with the former CDMO to continue with technical support through completion of the transfer. Keeping a contractual link with the prior CDMO ensured quick answers and accelerated the process. While there was an additional cost incurred by the sponsor, it was likely offset by time savings via cleaner knowledge sharing. It also reduced risk and increased the likelihood of a smooth transfer.
With a range of successful transfers from early-stage to commercial supply, the Lifecore team understands what it takes to transfer a project smoothly. We ensure that everyone is aligned on the process, the product, and the long-term goals. Our multi-disciplined team structure means project leads manage day-to-day work, identifying risks and escalating when needed; managers provide oversight and help to move decisions forward; and executives remain on hand to quickly provide higher-level guidance if required.
Plus, with deep experience in handling complex products, our technical experts are effective at addressing process development and manufacturing challenges throughout the transfer.
If you need help with tech transfer, contact us to explore how we could work together.