Cell Banks for Bioassays

Bioassay cells are considered critical reagents for implementation in lot release. Lot-to-lot reproducibility and consistent supply of the cells are some of the key factors that need to be addressed as part of the implementation process. Establishing a dedicated Master Cell Bank for manufacturing bioassay cells ensures a long-term supply of consistently-manufactured lots that deliver reproducible assays performance.

Confidently de-risk your biologics’ lot release strategy by establishing a dedicated analytical cell banks for your bioassay.

 

Eurofins DiscoverX Cell Banks for Bioassays
 
  • Extensively Tested – Well-characterized and QA-released banks to ensure long-term reproducibility for your bioassays implemented in lot release
  • Proven System – Dedicated, two-tiered analytical cell banks for critical reagents (bioassay cells) supply assurance
  • Long-Term Storage – Two-site secure storage to ensure continuous supply of bioassay cell lots for the lifetime of your therapeutic
 

Contact Us
 

Workflow for Cell Bank Manufacture to Bioassay Kit Delivery
 


* Optional off-site storage for working cell bank (WCB) vials

Characterization & Testing of Cells

 
Clone
Master Cell Bank 
(MSB)
Working Cell Bank 
(WCB)
Bioassay Cells
  • Cell Line Identity & Purity
  • Passage Stability
  • Sterility & Mycoplasma Testing
  • Functional Performance
  • Passage Stability
  • Sterility & Mycoplasma Testing 
  • Functional Performance 
  • Sterility & Mycoplasma Testing
  • Functional Performance Bioassay QC
  • Sterility & Mycoplasma Testing

* Optional cell testing: Viral and bacterial pathogens, cell line identity, compendial mycoplasma testing, and direct inoculation sterility testing available upon request

Cell Banks for Bioassays Project Process & Deliverables  


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Dedicated, Well-Characterized Analytical Cell Banks

Bioassays for potency testing are considered to be most challenging of the panel of assays that are implemented in QC lot or batch release of the biologic. It is also well-recognized that the inherent variability of the biological drugs as well as the biological test systems such as the cell-based assays, create significant challenges for establishing a robust bioassay that meets reliability requirements of the quality control (QC) environment, and in ensuring long-term assay reproducibility. Hence implementing a validated and highly-reproducible bioassay in lot release requires a robust development strategy as well as a well-defined critical reagent management plan for long-term supply assurance to support the biotherapeutics.

To address these challenges, firstly Eurofins DiscoverX offers the Industry’s largest menu of qualified and MOA-based ready-to-use bioassay kits that have been developed using stable cell lines, optimized and qualified with marketed innovator drugs (e.g. Avastin, Keytruda, Victoza, etc.), reference standards or ligands (e.g. anti-CD47 antibody). Each bioassay is developed to meet the QC requirements for linearity, accuracy, precision and robustness. These bioassays are available as complete kit and include cryopreserved cells and optimized reagents required to run the assay, thereby reducing the development and implementation timelines by at least 6 months.

Secondly, bioassay cells are considered critical reagents for implementation in lot release. Lot-to-lot reproducibility and consistent supply of the cells are some of the key factors that need to be addressed as part of implementation process. Establishing a dedicated Master Cell Bank (MCB) for manufacturing the bioassay cells ensures a long-term supply of consistently-manufactured lots that deliver reproducible assays performance, which addresses these requirements. 

Eurofins DiscoverX is an established leader in bioassay development and the expertise is leveraged in the production and testing of well-characterized analytical cell banks to meet your assay requirements as well as post-market support for your biotherapeutics.