Contract manufacturing (CMO)
A validated assay design is transferred into our WHO-GMP production lines and manufactured at scale, with full lot documentation from the first batch.
Transfer begins with a joint gap analysis of your device master record against our line capability. Raw-material equivalence, incoming QC specifications and critical process parameters are agreed before the first engineering lot.
Once the line is qualified, production runs to your specification with in-process controls at each critical step. Every lot is released with batch records and a certificate of analysis. Stability programs support your registrations in each market.
Lot documentation: batch records · CoA per lot · stability data on request
You bring
- Validated assay design and device master record
- Raw-material specifications and approved suppliers
- Release specifications and test methods
- Forecast volumes and packaging requirements
We deliver
- Joint gap analysis and technology transfer plan
- Line qualification and process validation
- Incoming QC and in-process controls to your specification
- Lot release with batch records and CoA
- Stability programs supporting your registrations
Discuss a technology transfer
Format, volumes and current manufacturing site are sufficient for an initial assessment.