Cell Banks for Bioassays

Ensure Long-Term Assay Reproducibility for Critical Reagents

Bioassay cells are considered critical reagents for implementation in commercial release and stability. Lot-to-lot reproducibility and consistent supply of the cells are key factors that need to be addressed as part of the implementation process. Establishing dedicated analytical cell banks – Master Cell Bank (MCB) and a Working Cell Bank (WCB) – 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 with Eurofins DiscoverX® for your bioassay.

 

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Program Highlights

  • 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 a continuous supply of bioassay cell lots for the lifetime of your therapeutic

Dedicated, Well-Characterized Analytical Cell Banks

It is well-recognized that the inherent variability in bioassays presents a significant challenge when implemented in a quality control (QC) environment, particularly when ensuring long-term assay reproducibility. Among other assay reagents, bioassay cells are considered critical reagents, and their lot-to-lot reproducibility and consistent supply are two focus areas that need additional attention as part of the implementation process. Establishing a dedicated MCB and WCB for manufacturing bioassay cells is a key success factor that ensures a long-term supply of consistently-manufactured lots that deliver reproducible assay performance.

 

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

Key Resources

Workflow for Cell Bank Manufacture to Bioassay Kit Delivery

Workflow for Cell Bank Manufacture to Bioassay Kit Delivery

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

Characterization and 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 and Deliverables

Cell Banks for Bioassays Project Process and Deliverables

WCB = Working Cell Bank, QC = Quality Control