BioInvent’s manufacturing facility provides capacity to produce antibodies for the Company’s preclinical studies and clinical trials, which is mandatory for a swift preclinical/ clinical development path. The manufacturing facility provides also the opportunity to manufacture and sell antibodies to external parties.
BioInvent Manufacturing, the contract manufacturing business unit of BioInvent International AB, has a proven track record for clients and partners and has offered CDMO/CMO services since 1988. The company has a French CIR (Crédit d’Impôt Recherche) accreditation. This simplifies for our French customers to claim up to 30% in tax credit for development and manufacturing activities performed at BioInvent.
BioInvent has produced drug substance for clinical trials in Europe, the USA, Japan, Australia and China.
Manufacturing capabilities
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 production. The processes include everything from cell line, formulation and analytical development to QP release of clinical grade material.
BioInvent offers a range of cell line development options that include a royalty free GS knocked CHO K1 cell line. BioInvent is conveniently located, in the university town of Lund Sweden, just 40 minutes from Copenhagen International Airport. The facility is licensed by the Swedish Medical Products Agency and is inspected on a regular basis; the last inspection was successfully concluded in 2023.
The highly experienced team at BioInvent Manufacturing provides flexibility and a proven collaborative approach to exceed our client’s goals.
Services available
- CDMO and CMO services
- cGMP manufacturing of clinical grade material (phase I to III) in 200 or 1000L SUBs
- Fully disposable manufacturing
- Cell line development
- Process development and process optimization
- Production of material for toxicological studies
- cGMP cell bank preparation and storage
- Analytical development
- Formulation development
- Management of Drug Product filling at collaboration partner
- Release testing and QP release
- Stability studies at multiple conditions
- Drug characterization
- Drug/material compatibility
- IMPD/IND preparation
Please contact [email protected] regarding your clinical manufacturing needs.