Cell Line Development
If you’re beginning your biologic upstream process development, BioReliance® End-to-End Solutions is your CDMO partner offering a custom approach to accelerate your 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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Figure 1.Cell line development experience.
Full 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
Plug & Play Upstream Development Service
Figure 2.From DNA to Clinic – Plug & Play Upstream Development.
Our Plug & Play Upstream Development Service is a tailored package that provides the solutions you need for your next step, from DNA all the way to clinic and Investigational New Drug (IND) filing. We are experts in optimizing speed with custom risk management, giving you the option to start process development early in parallel with cell line development, with our proprietary CHOZN® GS cell line.
Plus, BioReliance® End-to-End Solutions is a world-class expert in regulatory compliance, so you can expect regulatory excellence and support as standard for your cell line and upstream development program, including CMC documentation and IND filing where we have a 100% success rate.
Tailored solutions from cell line to upstream process 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
- Fast-track process using early material for process development, saving 10–13 weeks on overall project timeline
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About mAb development and manufacturing services
As a full-service biologics CDMO with deep expertise across all stages of biologic development and manufacturing, we offer flexible, custom 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
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.
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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