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Biotechpharma is a contract development and manufacturing organisation (CDMO) for biopharmaceuticals. We perform for our clients cell line construction and cloning, cell banking, analytical development, formulation development, upstream and downstream process development to scale up and cGMP production. Our clients get highest service in our state-of-the-art facility which is EU-cGMP approved. Biotechpharma can produce both, microbially based recombinant proteins and mammalian cell culture-based monoclonal antibodies (mAb´s) in up to 2000 L-batches. By offering our clients drug substance and drug product, clinical and commercial amounts, we serve our customers as true one-stop-solution.
Areas of expertise:
• cell line development and GMP-cell banking incl. storage of MCB and WCB
• process development of high productivity biosynthesis
• efficient protein refolding and downstream process development
• drug substance and drug product cGMP manufacturing
• technology transfer
• cGMP compliant analytical services
• process characterization and validation
• stable protein formulation development
• stability studies
• project management