Px’Pharma Added Value
Expression Systems & Capacities
Range of Services
Protein Engineering
Feasibility Assessment
Process Development
Cell Banking
Control Development
Clinical Manufacturing
QA & Regulatory Support

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Process Development   

Development and optimization of a production scheme compliant to GMP guidelines

•
Upstream process development (USP)
 

- Fermentation in batch or fed-batch mode
  (in 30L fermentor)
  - Cell disintegration
 
•
Downstream process development (DSP)
 

- Clarification
  - Centrifugation / Microfiltration
  - Tangential flow filtration
  - Advanced preparation of inclusion bodies and refolding   process
  - Ultra filtration
  - Purification by chromatography (ion exchange   chromatography, hydrophobic interaction chromatography,
   affinity chromatography, gel chromatography, etc.)



The process development phase will be validated by the production and release of one or several pilot batches which can be used for preclinical trials and other assays.

The completion of this step will validate the process which can then proceed, upon customer approval, to clinical production.
Protein'eXpert SA - PX'Pharma SA - Zone Minatec Entreprises -
7 Parvis Louis Néel – BP50 F - 38040 Grenoble
Phone: +33 (0)438 023 650 - Fax: +33 (0)476 961 038