Technology Transfer
Structured transfer of knowledge, documentation and manufacturing capability between sites and organisations.
Transfer the Process, Not Just the Paperwork
A technology transfer is complete when the receiving site can manufacture to the same quality attributes as the sending site — reproducibly, and with regulatory approval to do so. Sending the batch record across is the easy part.
We manage the full transfer: capturing tacit process knowledge, assessing equipment and site differences, adapting parameters, proving reproducibility through pilot and validation batches, and amending the dossier.
At a Glance
- R&D to production transfer
- Site-to-site and scale-up transfer
- Validation batches and dossier amendments
Need this scoped for your facility and target market? A senior consultant will give you a candid read at no cost.
Request a ProposalTypes of Transfer We Manage
Four common transfer scenarios.
R&D to Production
Moving a developed formulation from the laboratory into routine commercial manufacture.
Site to Site
Transferring an established product between manufacturing sites within or across organisations.
Pilot to Commercial Scale
Scaling from pilot batches to full commercial batch size with parameter re-establishment.
Contract Manufacturing
Transfer to a CMO, including the technical agreement and ongoing oversight arrangements.
Our Six-Stage Transfer Process
From knowledge capture to routine commercial manufacture.
Knowledge Transfer
Structured capture of formulation detail, manufacturing steps, critical quality attributes, critical process parameters and accumulated process know-how.
Gap Assessment
Systematic comparison of sending and receiving sites: equipment, scale, utilities, analytical capability, personnel and regulatory status.
Process Adaptation
Alignment of process parameters to the receiving site’s equipment train so the transferred process delivers equivalent output.
Pilot / Trial Batches
Trial manufacture at the receiving site to confirm reproducibility and product quality before committing to validation.
Validation Batches
Commercial-scale validation batches with full documentation demonstrating consistent, controlled manufacture.
Regulatory Approval & Routine Manufacturing
Dossier amendments, variation submission and authority approval, followed by transition to full routine production.
Services That Pair With This
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