Program Module
Technology Transfer
A process that works at one site is not automatically a process that works at another. Transfer succeeds or fails on how completely the knowledge moves, not on how well the documents are copied.
Overview
The knowledge that is not in the document
Every established process carries undocumented operating knowledge — the order in which reagents are actually charged, how an endpoint is judged in practice, which parameter the site quietly holds tighter than the specification requires. A document transfer moves the file. It does not move that knowledge.
The result is a receiving site that follows the written procedure and still produces material that fails comparability, then spends months rediscovering what the sending site already knew.
We run transfer as a project with both sites engaged, treating the gap between the written process and the practised process as the primary risk to be closed.
Both sites in the room
Sending and receiving sites work against one plan, so operating knowledge transfers directly rather than through a document round-trip.
Methods transfer with the process
Analytical methods are transferred and cross-validated alongside the process, because a comparability result is only as good as the method behind it.
Scale effects assessed up front
Mixing, heat transfer and hold-time behaviour change with scale. These are modelled and tested rather than assumed to carry over.
Comparability defined before transfer
Acceptance criteria are agreed at the start, so the question of whether the transfer succeeded has an answer both sites accept.
Process
Transfer stages
Duration depends on process complexity and on whether the receiving site has run comparable chemistry before.
- 01
Package assembly
The complete process package is assembled from the sending site — procedure, parameters, in-process controls, known deviations and the operating knowledge behind them.
- 02
Receiving site assessment
Equipment train, utilities, containment, analytical capability and operator experience are assessed against what the process requires. Gaps are identified before commitment.
- 03
Gap closure & method transfer
Equipment or capability gaps are closed and analytical methods are transferred and cross-validated so both sites measure the same thing the same way.
- 04
Engineering batches
Engineering and demonstration batches are run at the receiving site with the sending site engaged, and results are assessed against the agreed comparability criteria.
- 05
Validation & handover
Validation batches are executed against the approved protocol, documentation is finalised, and the receiving site takes ownership with a defined post-transfer monitoring period.
Questions
Frequently asked
Yes. Transfer is frequently run between a client's existing sites, or from a client site to a contract manufacturer, without any change to the commercial supply relationship.
Scope a transfer
Tell us the process, the sending and receiving sites, and the timeline you are working to.
Related
Other ways we can be engaged
How can we help you?
Receive insights into the latest events and regulatory updates
Sent directly to your email
Get industry insights and Unibest news here
Contact Us →