We have a proven track record for clients and partners since 1988 and over 25 years of inspections history with 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 meeting or exceeding our client’s goals. Our process development team uses a platform process to ensure rapid and successful development starting with cell line development to final release of drug substance.
Services available include:
- cGMP manufacturing of clinical drug substance up 1000L
- 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
For more information, contact Phil Wallace, Vice President Business Development, BioInvent Manufacturing at: firstname.lastname@example.org