GMP compliant Cell Line Development Service

Our GMP production cell line development service combines the use of powerful cGMP-compliant technology platforms 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 high quality therapeutic antibodies and proteins to the health market. Full regulatory-compliant process control is ensured.

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Custom GMP Cell Line Development Service

High Producer Cell Line & GMP-compliant Technology Platforms

Benefit from trenzyme´s long-standing expertise in GMP-compliant cell line development. Our fully controlled, regulatory-compliant processes, which include LIMS-based documentation and a full audit trail, enable the generation of GMP-compliant cell lines that can be used from the research and development phase through to the successful launch of high-quality therapeutic antibodies and proteins onto the healthcare market.

The development of highly productive production cell lines and efficient assay cell lines represents a significant challenge for any pharmaceutical developer or service provider, particularly when subsequent Good Manufacturing Practice (GMP) compliance is required in order to fulfil all relevant pharmaceutical guideline specifications. As a reliable partner for the biotechnology and pharmaceutical industry, with many years of experience in cell line development, we provide industry-leading CHO-based, GMP-compliant technology platforms for the generation of high-performance, clonal production cell lines.

To optimally meet your specific project requirements, we always work in close collaboration with our clients to ensure transparency, high quality and maximum success.

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Process of GMP compliant Cell Line Development Service

Under Regulatory compliant Conditions

Process of GMP Cell Line Development Service_trenzyme GmbH

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Further Service Options_trenzyme_Cell Culture Services

Further Options

GMP Cell Line Development Service

Highly flexible and tailor-made solutions for your application. If you require an option that is not listed, please contact us – we will find the ideal solution for you:

  • We are able to provide all our cell line services in accordance with GMP standards. Please let us know your specific project requirements – we look forward to supporting you!
  • In addition to the most commonly used mammalian cell lines (CHO, HEK293), we are able to generate stable cell lines derived from different species (e.g. insect cell lines HighFive, Sf9, yeast or E.coli) in full compliance with GMP guidelines, that are precisely adapted to meet your specific requirements
  • If GMP compliance is not required, we offer the generation of production/assay cell lines as part of our custom stable cell line development service.

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

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Your Way from R&D to Market

Process from GMP Cell Line Development to Your Final Product

GMP compliant Cell Line Development Service_trenzyme GmbH_Process from R&D to Market

What Our Clients Say About Us

It was a pleasure to work with trenzyme. Our expectations were fully met. trenzyme’s team of professional scientific experts helped us to complete our objectives in time. We were also pleased with the quality of the documentation provided. In a nutshell, I can recommend trenzyme as a reliable service provider.

Michael Samassa Celonic AG, Basel, Switzerland
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GMP-compliant Cell Line Development Service FAQs

Which parental cell lines do you use?

We use Celonic’s CHOvolution® CHO-K1 and Thermofisher’s Freedom ExpiCHO-S™ as parental cell lines. Other cell lines on request.

What is the final productivity of the cell line after cell line development?

As a high standard productivity, we can reach up to 3g/l for mABs after cell line development. After process development, it can reach > 8 g/l.

Which type of license do you offer?

Within the cell line generation at trenzyme, a R&D license is already included and has not to be purchased. For any commercial application later on, a commercial license is needed.

See General FAQs
antje fuhrmann application & sales manager trenzyme
Antje Fuhrmann, PhD
Application & Sales Manager

We would be happy to provide you with support on your cell research project. Contact us and let us know your questions and requests to our cell services. Our scientific experts will reply shortly.

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