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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: service@glycotope.com

Dr. Lars Stöckl