Merck

Cell Line Development

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If you’re beginning your biologic upstream process development, our cell line experts offer a custom approach to cell line development. By listening to you, we offer the solution that’s right for your needs with the optimal balance of cost, risk, and speed to clinic – whether your biomolecule is a monoclonal antibody, bispecific antibody, ADC, or a fusion protein.


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MAMMALIAN Cell Line Development Capabilities

Our full cell line development capabilities and expertise span from DNA and vector constructs to top clonal selection, research and master cell banks, and stability studies. We have a wealth of experience across a wide range of mammalian cell lines, expression platforms, biomolecules, and scales.

Plus, we give you the flexibility either to develop your mammalian cell line with us from the start, or we can seamlessly transfer your existing cell line to our facilities. We have the capacity to perform cell line pre-studies for vector optimization, variant and signal peptide screening, and early material generation for your toxicology studies or pilot runs.

“Good project management and good anticipation of decisions.”

— Client quote about our CDMO services


MAMMALIAN CELL LINE DEVELOPMENT IN PARALLEL TO PROCESS DEVELOPMENT

The image is an infographic that outlines the drug development process from DNA to Clinic. It is divided into three main sections, each with a different color and icon. The DNA section in pink includes the steps in-silico codon optimization and establishing stable pools. The Preclinical section in pink covers choosing the right clone, obtaining quality material for studies, creating a high-producing stable cell line, and documenting monoclonality and stability. The Clinic section in pink details establishing a master cell bank, preparing documentation for IND filing, and acquiring GMP supply for clinical trials.

Figure 1.From DNA to Clinic – Plug & Play Upstream Development.

When choosing our Plug & Play Upstream Development Service, customers benefit from a full-service package and tailored solutions, including:

  • Flexibility to choose our proprietary CHOZN® GS cell line or any mammalian cell line
  • Full cell line development services from your molecule of interest to your top clone selection and master cell bank
  • Monoclonality reports and stability validation in compliance with regulatory expectations
  • IND submission support and CMC documentation
  • Add-on services for advanced analytical method development and product characterization

Our Track Record

About OUR MAMMALIAN BIOLOGICS CDMO

With 35+ years of experience, we provide deep expertise and flexible solutions for mammalian cell line and process development, media and feed screening, master cell banking, scale-up and GMP clinical and commercial drug substance manufacturing, with analytical methods development, validation, and testing all in-house. Working with you, we’ll balance risk to optimize your speed and support all aspects of regulatory compliance on your journey to market.

To reach your next milestone, reach out to us.


Related Webinars

A digital illustration of a laptop displaying a simplistic human figure next to a pink rectangle, all set against a yellow background.
Accelerate Delivery of High Producing Cell Lines

In this webinar you will learn how the strategy approach can help reduce the overall timeline of cell line generation, how we have expanded our platform by designing a vector/cell/process template, and how we have worked on promoters, enhancers, pool/mini-pool approach as well as on timelines from DNA to clone.

A digital illustration of a laptop displaying a simplistic human figure next to a pink rectangle, all set against a yellow background.
Reaching Clinical Stage Development with a CHOZN® Cell Line

In this webinar, we present the way we support our customers thanks to the advantages provided by the CHOZN® cell line, and a specific strategy for clone selection where semi-automation and pool selection are leveraged, to get it right the first time.



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