Protein Purification and Characterisation
For the enrichment of a specific protein required and its separation from foreign products, cell culture harvests have to be purified by applying a cascade of different physico-chemical separation techniques. For this purpose, individual steps of a purification process are usually scouted at small scale before a GMP production process is developed and optimised. Suitable analytical assays for in-process-controls or final quality controls have to be developed and integrated into the process in order to ensure compliance with specifications. |
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Analytical methods as well as the related GMP-scale production steps have to be validated according to the relevant guidelines.
Intermediate and final products are subject to stability examinations for confirmation of appropriate storage conditions and expiry dates.
ORPEGEN Pharma offers all these protein-chemical tasks from scouting the separation parameters till development of the whole purification scheme, validation of the relevant process steps as well as stability testing procedures by application of the appropriate analytical portfolio.