Technology transfer
For manufacturers who want to make insulin or peptides themselves: our process, documents and training for your plant.
- Project and site review
We agree the molecule, the scope and what the receiving site needs.
- Process and test package
We align the process documents and the test methods.
- Transfer plan
We set who does what, the training and the milestones.
- Start-up and proof
We run the process at your site against agreed acceptance criteria.
What our process teams bring
- Expression on several hosts: E. coli, Pichia pastoris and HEK293 cells.
- Chromatography: affinity, ion exchange, hydrophobic and mixed-mode.
- Continuous-flow process development.
- Pilot and 100 L scale technology transfer.
- Risk assessment of every purification step.
- Protein activity testing and a CMC quality system for drug substances.