| Clinical Manufacturing |
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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.
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