Feasibility
Assessment
As part of the clinical manufacturing programme,
PX’Pharma will first assess the biopharmaceutical’s ability to be manufactured
under GMP environment.
Option A – No production history for the protein of interest
In case where no protocol is to be transferred by our customer
or detailed in the literature, PX’Pharma will perform a complete feasibility
study in order to assess the protein’s ability to proceed to GMP production.
• Bibliographic study
• Selection and evaluation of strains, plasmids and vectors compatible with GMP process
• Expression, solubility and capture tests
• Development and optimization of a production and purification scheme
(small scale, research grade)
Option B – Production protocol available (from the client , from literature)
The feasibility study will include:
• Protocol transfer, reproduction and validation
• Selection and evaluation of strains, plasmids and vectors compatible with GMP process
• Expression, solubility and capture tests
• If required, optimization of the production and purification schemes (small scale, research grade)