Business Units
ORPEGEN Pharma has four main business units:
- Biotechnological Contract Manufacture and Development
- Peptide Chemicals (Amino Acid Derivatives and Pharmaceutical Peptides)
- Diagnostics in Cellular Immunology
- Contract R & D
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.
The current maximum production capacitiy is quoted to be 5,000 litre per GMP unit and batch. We are prepared to run 4 production units in parallel.
Peptide Chemicals
The main focus of the Peptide Chemicals department is the production of pharmaceutical grade amino acid derivates and peptides on an industrial scale. The unit produces more than 350 amino acid derivates, including all N-protected amino acid tert.-butylation derivates, in multiple kilogram to ton quantities and peptides at kilogram scale.
The company is also specialized in the synthesis of antigenic determinants and conjugations to carrier molecules for the development of vaccines.
The maximum capacity for individual sequences of up to about 32-mer peptides ranges at multiple kilogram syntheses in both solution and solid phase.
Diagnostics
Based on the application of flow cytometry 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. 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 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 ORPEGEN Pharma provides documentation compliant to application standards in required format and consultative support in the communication with regulatory authorities.