About Glycotope Biotechnology
Since more than 25 years in operation, Glycotope-Biotechnology GmbH (the former manufacturing and diagnostics unit of Orpegen GmbH) is a fully GMP-compliant an one of the most-experienced and contract manufacturing organisations in Germany.
Equipped with 4 independent GMP-production suits for fed-batch and perfusion fermentation of mammalian cell-lines, Glycotope-Biotechnology GmbH offers the entire process of biopharmaceutical manufacturing from the clone to the drug ready to be administered in clinical trials.
From process development, design and implementation of USP- and DSP-processes, quality-control & analytics down to aseptic Fill & Finish and release of the drug substance, Glycotope-Biotechnology GmbH has a long-lasting track-record as a reliable and innovative partner for the pharmaceutical industry.
Additional R&D services offered include transfection, clone selection and cell line development, MCB and WCB establishment and characterisation, product characterisation, validation studies and process optimisation.
These services are supported by research and development in immunology, cell biology, molecular biology and protein chemistry. Based on the GlycoExpress technology of Glycotope GmbH, Berlin, we offer the development and production of pharmaceutical proteins and antibodies in human cell lines with an optimised glycosylation pattern.
Glycotope Biotechnology complies with all criteria specified by the European Pharmaceutical legislation, the European Pharmacopoeia, and the EU and ICH guidelines.
Glycotope Biotechnology GmbH is a full subsidiary of Berlin-based Glycotope GmbH and well integrated into the surrounding scientific and industrial community. Our R&D departments work closely together with the scientists at the German Cancer Research Centre and the University in Heidelberg. Within the last 2 years, the company has grown from 35 to 55 employees and plans to significantly expand further in the near future.
With currently more than 130 employees, the Glycotope group represents one of the largest biotechnology organisations in Germany. The two currently ongoing clinical trials for Glycotope´s oncology pipeline of glyco-optimized monoclonal antibodies underline Glycotope-Biotechnology’s capability to produce and finish products at the highest and GMP-compliant quality within short time.
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