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.
Our clients and partners from the pharmaceutical and biotechnology industry rely on our highly-customized cell services and benefit from our longstanding expertise and in-depth know-how on stem cells and stable expression of recombinant protein in different cell lines.
To optimally support our clients’ needs, we always work in close collaboration with our clients to ensure transparency, high quality and maximum success.
What clients say about us
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 PiskunovGenerium Pharmaceuticals
Process from cell line development to production
under regulatory-compliant conditions
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