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 Production of Proteins

Our core competencies:

• 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

Glycotope Biotechnology performs the purification of cell-free harvest in a monitored hygienic area corresponding to ISO class 7.