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Process
DevelopmentDevelopment and optimization of a production scheme compliant to GMP guidelines
• Upstream process
development (USP)
- Fermentation in batch or fed-batch mode• Downstream process development (DSP)
(in 30L fermentor)
- Cell disintegration
- 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.
Zone Minatec Entreprises - 7 parvis Louis Néel - BP50 F 38040 Grenoble
Phone: +33(0)438 023 650 - Fax: +33(0)438 961 038
Phone: +33(0)438 023 650 - Fax: +33(0)438 961 038