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GMP Production

PX’ ensures the production of your biologicals according to the Good Manufacturing Practices.
Multiply the chance of success for your projects!

 

 

You work on:

A soluble or insoluble protein or a peptide

Monoclonal or polyclonal antibodies

An antibody fragment

scFv, VHH, VH, Fab…

Cells or microorganisms, natural or modified

PX’Therapeutics, a CDMO expert in bioproduction according to GMP standards, has manufactured dozens of active substances and released several final products for clinical trials that have been authorized by various national agencies (France, US, UK, Belgium, Netherlands, etc…).

 

 

 

Our goal


 

Give the best chances of success to your pre-clinical or clinical trial, by producing your biologicals according to the requirements of quality, and robustness, respecting the deadlines, and assisting you in the regulatory process.

 

Our offer


 

 

  • Production of lots according to processes developed by PX’ or by other laboratories.
  • Production of MCB/WCB cell banks  (bacteria, yeast and mammalian).
  • Active substances manufacturing and formulation.
  • Coordination of filling steps with qualified partners.
  • Final products certification by our Qualified Person.
  • Composing the batch documentation and its verification by our Quality Assurance Department.
  • Fluid transfer of processes to CMOs specialized in large scale manufacturing.

PX’ expertise in GMP production