Business Units
Glycotope Biotechnology has three main business units:
Biotechnological Development and Production The main focus of this business unit is GMP contract manufacturing of pharmaceutical antibodies and recombinant (glyco-)proteins. In addition, the biotechnology group offers R & D services for recombinant protein expression including cell line development, MCB or WCB establishment and characterisation, product characterisation, validation studies, process optimisation. |  |
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Diagnostics
Based on the application of flow cytometry Glycotope Biotechnology (former: ORPEGEN Pharma) is providing several novel and proprietary clinical diagnostics in cellular immunology. On small human whole blood samples the diagnostics allow fast and precise quantifications of immune functions such as chemotaxis, phagocytosis, oxidative burst, basophil degranulation, NK activity, thrombocyte differentiation and reactivity.
MHC Tetramers have set the standard in the quantification of antigen-specific T cells. Tracking T cells with Tetramers has rapidly replaced older assays requiring extensive ex vivo manipulation. Monitoring T cell responses is now possible in a range of infectious dieseases, cancer research and vaccine development.
The focus of the department is the development and production of ready-to-use diagnostic kits. Glycotope Biotechnology (ORPEGEN) kits received the European CE label and are certified for research and clinical applications as well. See also Products.
Contract R & D Services
Since more than 20 years Glycotope Biotechnology (and his predecessor ORPEGEN Pharma) is performing R&D services to clients in molecular and cell biology, immunology and protein chemistry. Additional R&D services offered include transfection of animal cells, clone selection and cell line optimisation, analysis of expression profiles, stability studies on pharmaceutical proteins, generation, testing and characterisation of GMP compliant master (MCB) and working cell banks (WCB).
A dedicated Quality Assurance (QA) department garantees fully GMP compliant production, as well as testing and documentation standards in accordance with the EMEA and ICH requirements.
As part of a GMP project Glycotope Biotechnology provides documentation compliant to application standards in required format and consultative support in the communication with regulatory authorities.