Technology transfer basics
Technology transfer is the move of a manufacturing process or an analytical method from one site to another. The site that hands over the process is often called the sending unit, and the site that takes it on the receiving unit. It happens when a process moves from your laboratory to a CDMO, from one CDMO to another, or to a larger plant as a product nears approval.
What gets handed over
The receiving site needs everything that defines the process, and the knowledge behind it.
- The process description and batch records.
- Raw material lists, suppliers, and specifications.
- Analytical methods, specifications, and reference standards.
- For biologics, the cell bank.
- Development reports, known risks, and past deviations.
Much of what makes a process work is never written down. Plan time for the people who ran it to talk to the people who will.
The usual steps
A transfer starts with a plan that sets out the scope, roles, and acceptance criteria. The receiving site then compares its equipment, scale, and materials with yours and lists the gaps. Analytical methods are usually transferred first, by comparative testing between the two sites, by joint validation, or by validating again at the new site. Engineering or demonstration runs follow to show the process works on the new equipment, before batches are made under good manufacturing practice.
Showing the product has not changed
When a process moves site or scale, you need to show that the product made at the new site matches the product made before. For biologics this is a comparability exercise, based on analytical comparison and sometimes more. Decide early what data you will need and agree it with the receiving site.
Regulators
A change of manufacturing site usually has to be reported to the regulators that hold your filings, whether for a trial or an approved product. Find out what is needed and build that time into the plan.
Where transfers go wrong
Common problems are knowledge that was never written down, raw materials that differ between sites, equipment that behaves differently at another scale, and analytical methods that were not robust in the first place. A gap assessment done early catches most of these before they cost a batch.
What to ask a receiving site
Ask who will lead the transfer, how they run gap and risk assessments, how they transfer analytical methods, and which similar processes they have taken on. Ask to see a transfer plan from a past project with the client details removed.