cGMP manufacturing PX’Pharma performs API production for clinical trials phases I-II in
accordance with GMP guidelines.
- Expression systems: bacterial & yeast
- Capacities: up to 100g protein batches (100L fermentation volume)
The clinical grade material manufactured is released in sterile bulk
format with full
documentation (SOPs, controls in process and on finished product).
Fill and finish operations (aseptic filling of vials, freeze-drying,
others) can be sub-contracted
to partners under the responsibility of Px’Pharma.
Chemical modifications, conjugation, stability assays can be performed
either by PX’Pharma
or with partners.
PX’Pharma will ensure the technology transfer to third parties.