GMP Production Cell Line Development
Cell line development is one of the most challenging tasks for any drug developer or service provider, especially if subsequent GMP compliance is a requirement. Our GMP production cell line development service combines the use of the powerful SEFEX CHO-K1 platform and our longstanding cell line development experience. It results in a highly productive GMP-compliant cell line suitable for use from the R&D phase up to successful introduction of therapeutic proteins and antibodies to the market. Full GMP-compliant documentation is provided.
High producer cell line & cGMP compliant technology platform
Our production cell line development technology platform is based on Celonic‘s proven SEFEX CHO-K1 cell line, which is adapted to serum-free EMA- and FDA-compliant media. This system has a standard productivity of up to 42 pcd (> 3 g/l) after cell line development and can reach up to 50 pcd (> 7 g/l) after process optimization. The SEFEX CHO-K1 cell line is characterized by high scale-up stability from small scale research to GMP manufacturing levels. It is already used in many production facilities in Europe, the US and Asia for target production up to 1000 liter scale.
After completion of the production cell line development process, your resulting research cell bank (RCB) can be transferred to a CDMO (Contract Development and Manufacturing Organization) of your choice (e.g. Celonic AG) for further process development, optimization and high level production. License fee payment is only charged once after R&D phase and your positive decision to proceed with GMP manufacturing.
“Our GMP-compliant production cell line development project was performed professionally and qualitatively. We thank trenzyme for the good collaboration and hope for future projects.”Dr. Aleksandr Piskunov
Process from cell line development to production under regulatory-compliant conditions
Benefits & Features
- SEFEX CHO-K1 platform: Cell line based on CHO-K1 (non-genetically modified CHO, Celonic AG) adapted to serum-free EMA- and FDA-compliant media
- High standard productivity up to 42 pcd (> 3 g/l for mABs) after cell line development – up to 50 pcd (> 7 g/l for mABs) after process optimization
- Ideal platform for new biological entities (NBE) or biosimilar products
- Saves time and money: GMP compliant, from R&D phase to market manufacturing
- Free of 3rd party IP: Upgrade your cell line after R&D for commercial use by a one-time license fee payment
- Cell line is already used in clinical trials in the EU, the US and Asia
- Benefit from the expertise of a reliable and longstanding cell line development service provider
- Full audit trail and documentation due to use of laboratory integrated management (LIMS) software throughout the whole development process
- High quality management standards: ISO 9001:2008 certified company
Antje Fuhrmann, PhD
Application & Sales Manager
We would be happy to provide you with support on your cell line research project. Let us know your questions and requests, our scientific experts will reply shortly.