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Downstream processing & protein purification
Process development services
Downstream processing & protein purificationDownstream processing is the recovery and purification of
biopharmaceuticals. It is an essential step in the manufac-
ture of recombinant biotherapeutics, which follows the up-
stream processing.
Development of purification processes
In the development of downstream processes (DSP) the
structural and functional parameters of the recombinant
protein must be retained while simultaneously all potential
impurities are removed. We perform method development
for protein purification processes including filtration (cell
separation and TFF/diafiltration development) and captur-
ing from harvest, through scouting for convenient chroma-
tography methods (IEC, SEC, HIC, RP, multimodal and affinity)
in order to achieve an efficient removal of host cell proteins
(HCP), culture medium components, endotoxins and host
cell DNA as critical impurities.
Formulation development
Denaturation of proteins during long-term storage must be
avoided. Most prominent problems are aggregation, frag-
mentation, deamidation, and oxidation. Glycotope uses ac-
celerated stress studies for the liquid or lyophilized storage
buffer to optimize the stability of your protein.
Our core competencies Process development ready for tech-transfer and
scale-up to pilot and production level Optimization of existing processes DoE, robustness tests Formulation development Stability studies under R&D Considering purity demands in accordance with
GMP guidelines
ISO 9001 compliant purification of proteins
We offer ISO 9001 compliant purification processes to ensure
controlled quality and safety of biopharmaceutical proteins.
For more information please contact us
Glycotope GmbH Robert-Roessle-Str. 10 Phone: +49 30 9489-2600
www.glycotope.com 13125 Berlin · Germany E-mail: [email protected]
Dr. Lars Stöckl