The BioInvent manufacturing facility is compliant with current Good Manufacturing Practice (cGMP) regulations and is fully based on disposable technology and can produce batches in sizes from 40 L to 1,000 L. The platform process ensures rapid and efficient process development and spans everything from cell line development to final release of drug substance for clinical trials. BioInvent offers a range of cell line development options that include a royalty free GS knocked CHO K1 cell line.
BioInvent Manufacturing, the contract manufacturing business unit of BioInvent International AB, 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 25 years, BioInvent Manufacturing has produced drug substance for clinical trials in Europe, the USA, Japan and Australia. BioInvent is conveniently located just 40 minutes from Copenhagen International Airport.
The highly-experienced team at BioInvent Manufacturing provides flexibility and a proven 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.
Services available include:
- cGMP manufacturing of clinical drug substance up to 1000L using single use technology
- Cell line development
- Process development and process optimization
- cGMP cell bank preparation and storage
- Analytical development
- Formulation development
- cGMP protein stability studies
- Regulatory filing preparation
Contact Kristoffer Rudenholm Hansson at firstname.lastname@example.org regarding your clinical manufacturing needs.