Glycotope - Leader in Optimising the Glycosylation of Biopharmaceuticals

Glycotope is a global leader in optimising the glycosylation of biopharmaceuticals. With GlycoExpressTM the company offers one of the broadest platform technologies for the screening, development and production of glycosylated proteins.

Development and production of biopharmaceuticals

The clinical pipeline of four various types of products and targeting different indications underlines Glycotope´s and its manufacturing arm Glycotope Biotechnology´s competence to develop products that promise a significant improvement for healthcare. In parallel, Glycotope and Glycotope Biotechnology offer the entire range of contract R&D and manufacturing services from the gene down to the finished product. After tremendous growth in the past years and now with more than 140 employees, Glycotope is among the largest Biotech companies in Germany.

Technology

GlycoExpress^TM is a unique and regulatory approved development and production technology based on a set of fully human cell-lines glycoengineered to deliver an improved glycosylation. Unmatched in its applicability, the system allows the improvement of activity, half-life time and immunogenicity for both antibodies and non-antibody proteins. Developed entirely by Glycotope and with superior production yields, the system permits an independent and cost effective development of improved biotherapeutics, coupled with a full patent protection.

Pipeline

Glycotope currently investigates four products in clinical studies, both NBEs and improved follow-on biologics (BioBetters). The three anti-tumor antibodies and the protein-hormone FSH-GEX, all in phase I and progressing to phase II throughout 2012, have underlined Glyco- Express^TM suitability to improve all classes of glycosylated proteins in multiple aspects. A further range of biopharmaceuticals is in various pre-clinical stages.

Manufacturing including Fill & Finish

For many years Glycotope Biotechnology has been a competent and fully GMP compliant manufacturing partner for the pharmaceutical industry and one of the first producers of recombinant proteins in Germany. Four independent GMP-production suites allow fed-batch and perfusion fermentation of mammalian cell-lines.

From USP & DSP, Cell-Banking, Analytics down to Fill & Finish, the company provides its customers with the complete range of contract manufacturing services necessary for a drug ready to be administered in clinical trials.

History

• 2011 TrasGEX™ and FSH-GEX™ start Phase I Expansion of DSP-capacities for production of up to 7 kg recombinant antibodies per year
• 2010 Glycotope´s first BioBetter product CetuGEX™ starts clinical trial. Initial operation of 2 x 300 L perfusion reactors having a batch volume of up to 9,000 L each
• Glycotope enrolls first patients in Phase I trial for its lead antibody PankoMab-GEXTM
• 2009 GlycoExpress receives regulatory approval Glycotope Biotechnology approved for „Fill and Finish" of clinical grade material
• 2008 Glycotope acquires manufacturing arm of Orpegen Pharma and forms Glycotope Biotechnology as GMP-Production unit of Glycotope. Orpegen Pharma was founded in 1982 in Heidelberg and among the first GMP producers of recombinants in Germany (rhEPO in 1989, monoclonal antibodies in 1999)
• 2007 Glycotope wins Jossa Arznei GmbH as investor in one of the largest series A financing rounds in European Biotech history
• 2004 Orpegen inaugurates new multi-purpose biotechnology facility
• 2001 Foundation of Glycotope on the Biotech Campus in Berlin Buch

Contact

Glycotope GmbH
Robert-Roessle-Str. 10
D-13125 Berlin, Germany
+49 (30) 9489 2600
Fax: +49 (30) 9489 2609
Email: info@glycotope.com
URL: www.glycotope.com

Glycotope Biotechnology GmbH
Czernyring 22
D-69115 Heidelberg, Germany
Tel: +49 (6221) 9105 0
Fax: +49 (6221) 9105 10
Email: info@glycotope-bt.com
URL: www.glycotope-bt.com