GMP Production Cell Line Development
Production cell line development is one of the most challenging tasks for any drug developer or service provider, especially if subsequent Good Manufacturing Practice (GMP) compliance fulfilling all relevant pharmaceutical guideline specifications is a requirement. Our GMP production cell line development service combines the use of the powerful CHO-K1 CHOvolution platform and our longstanding cell line development experience as a partner for companies in the biotech and pharmaceutical industry. It results in a highly productive GMP-compliant cell lines suitable for use from the R&D phase up to successful introduction of high quality therapeutic antibodies and proteins to the health market. Full regulatory compliant process control is ensured.
High producer cell line & cGMP compliant technology platform
Our GMP-compliant production cell line development technology platform is based on Celonic’s high quality CHO-K1 CHOvolution cell line, which is adapted to serum-free EMA- and FDA-compliant media. This system has a standard productivity (> 3 g/l) after cell line development and can reach > 8 g/l after process optimization. Due to Celonic’s proprietary serum-free expression platform technology (SEFEX), the CHO-K1 originating CHOvolution cell line is characterized by high scale-up stability from small scale research to GMP manufacturing levels and is already used in many manufacturing facilities in Europe, the US and Asia for target production up to 1000 liter scale.
After completion of the production of cell line development process, your resulting high quality research cell bank (RCB) can be transferred to a CDMO (Contract Development and Manufacturing Organization) of your choice 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
- CHO-K1 CHOvolution platform: Cell line based on CHO-K1 (non-genetically modified CHO, Celonic AG) adapted to serum-free medium which is compliant to the EMA- and FDA-Guidelines
- High standard productivity (> 3 g/l for mABs) after cell line development and > 8 g/l for mABs after process optimization
- Ideal platform for new biological entities (NBE) or biosimilar products
- Saves time and money: Good Manufacturing Practice-compliant (GMP), 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
- GMP-compliant cell line is already used in practice: e.g. for drugs 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 all highly controlled development phases
- High quality management standards: ISO 9001:2015 certified company
GMP-compliant Production Cell Line Development
Antje Fuhrmann, PhD
Application & Sales Manager
We would be happy to provide you with support on your GMP-compliant production cell line development project. Contact us and let us know your questions and requests regarding our GMP production cell line development service, our scientific experts will reply shortly.
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