BPC Arnold GmbH BioPharma Consulting Über uns
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BPC Arnold GmbH BioPharma Consulting was founded by Dr Stefan Arnold in April 2014 to provide customers in the biopharmaceutical field with individual support in process development and project management. His in-depth expertise in biopharmaceutical development enables individual project valuations for a proper portfolio selection and implementation. Special field is biosimilar development.
• Biopharmaceutical development - special field: biosimilar development
• Definition of process strategy (expression, fermentation, purification)
• Process development for GMP API manufacture. USP and DSP
• Protein formulation, drug product development
• Process improvement and adjustment
• Bioassay development
• Planning and conduction of comparability exercise
• for biosimilar development
• for process transfer
• for scale up of process
• for change of manufacturing site
• for process changes with type II variations
• Trouble shooting in development and manufacture
• P roject valuation for biopharmaceutical portfolio selection
• CMC Due Dilligence for biopharmaceutical M&A processes
• Interim project management up to clinical phase I
• Network to relevant CMOs and CROs
