Driven by complex modalities, global supply chains, and strategic partnerships, increased outsourcing makes tech transfer a critical process for both CDMOs and sponsors. Tech transfer is an intricate undertaking often a “you don’t know what you don’t know” situation for newcomers, and even a demanding data-gathering trial for those with experience. Working with an experienced CDMO can clarify the path forward.
What’s at Risk If Tech Transfer Goes Wrong
Every tech transfer is unique in some way, and the consequences of getting details wrong can be significant. The greatest risk would be the inability to produce a safe, high-quality product–something no sponsor or CDMO could accept as an outcome. On the path to ensuring safety, quality, and compliance, ineffective or inefficient tech transfers involve additional risks such as repeated development work, regulatory scrutiny, added time and expense, and increased stress on resources. All of the above can delay a programme’s next steps or even postpone a product launch. Getting tech transfer right matters in the long run.
Knowledge Transfer
Tech transfer is not simply moving a product from one organisation 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.
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 sometimes 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.
The Information Sweet-Spot
With documentation, there is also an information “sweet spot” for the receiving CDMO. Too little information forces the receiving team to make assumptions or do duplicate work. Conversely, too much detail, especially if it is not well-organised, 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 programme 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. For example, 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.
