BioInvent Manufacturing is seeking clients requiring cGMP manufacturing services for clinical grade drug substance for use in Phase 1 to Phase 3 clinical trials.
BioInvent Manufacturing, the contract manufacturing business unit of BioInvent International SA, has a proven track record for clients and partners since 1988 and over a 25 years’ history of inspections from regulatory authorities. Using single use technology for more than 15 years, BioInvent Manufacturing has produced drug substance for clinical trials in Europe, the USA, Japan and Australia.
The highly-experienced team at BioInvent Manufacturing provides flexibility and a collaborative approach to exceeding our client’s goals. Our process development team uses a platform process to ensure rapid and successful development of mammalian expression systems starting with technology transfer or cell line development to final release of drug substance.
• cGMP manufacturing of clinical drug substance up 1000L using single use technology
• Process development and process optimization
• cGMP cell bank preparation and storage
• Analytical development
• Formulation development
• cGMP protein stability studies
• Regulatory filing preparation
• Cell line development