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 powerful cGMP-compliant technology platforms 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 platforms
Our cGMP-compliant production cell line development process is based on the proven and industry leading CHO-K1 or Freedom ExpiCHO-S™ systems for the manufacturing of antibody and non-antibody proteins. Both systems have a high scale-up stability from small scale research to cGMP manufacturing levels.
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. The generated cell line can be easily upgraded for commercial use after the R&D phase by a one-time license fee payment (royalty-free).
Benefits & Features of our cGMP-compliant technology process
- CHO-K1 or Freedom ExpiCHO-S™ system for manufacturing of antibody and non-antibody proteins
- Transient production for fast-delivery of your target protein possible to start DSP process
- Evaluation of cell viability and target manufacturability at early-stage development
- Comprehensive characterization of minipools and clones in fed-batch cultures
- Maximum flexibility: Optional development of multiple cell lines in parallel to the pool stage and selection of a lead candidate for further cell line generation
- High scale-up stability from small scale research to cGMP manufacturing levels
- Confidence in advance of your cGMP manufacturing campaign through extended stability studies
- Provision of cGMP-compliant RCBs and tech transfer to the CDMO of your choice
- 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