Downstream Processing/ Protein Purification
Downstream processing is the recovery and purification of biopharmaceuticals. It is an essential step in the manufacture of recombinant biotherapeutics, which follows the upstream processing, also called fermentation.
Development of Purification Process
In the development of Downstream Processes (DSP), the structural and functional parameters of the recombinant protein must be retained while simultaneously all potential contaminants are removed. We can perform the method development for protein capturing from harvest, through scouting for convenient chromatography methods (IEC, SEC, HIC, RP, Affinity) in order to achieve an efficient removal of host cell protein (HCP), endotoxins and host cell DNA as critical impurities.
GMP Compliant Purification of Proteins
We offer GMP compliant purification processes to ensure the final product meets all regulatory guidelines. Glycotope Biotechnology performs the purification of cell-free harvest in a monitored hygienic area corresponding to ISO class 7 (corresponding to class C rooms).
- Scale-up to pilot and production levels
- Process validation according to GMP guidelines
- Validation of viral safety
- Production for clinical trials phases I-III in accordance with GMP guidelines
