Cell Banks for Bioassays

Ensure Long-Term Critical Reagents Supply and Assay Reproducibility

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 2-tiered analytical cell banks: Master Cell Bank (MCB) and a Working Cell Bank (WCB), ensures a long-term supply of consistently-manufactured lots of bioassay cells 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.

Product 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.

Workflow for Cell Bank Manufacture to Bioassay Kit Delivery

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

Characterization and Testing* of Cells

CloneMaster Cell Bank
Working Cell Bank
Bioassay Cells
Cell Line Identity & PurityFunctional PerformanceFunctional PerformanceFunctional Performance Bioassay QC
Passage StabilityPassage StabilitySterility & Mycoplasma TestingSterility & Mycoplasma Testing
Sterility & Mycoplasma Testing
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

WCB = Working Cell Bank, QC = Quality Control

Videos Cell Banking for Bioassays

Learn how to confidently de-risk your biologics’ lot-release strategy by establishing a dedicated analytical cell banks for your bioassay. Find…

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Blogs & Articles Accelerating Biologics Therapeutics with Bioassays: An In-Depth Discussion on the Essence of Bioassays Implemented for Drug Development

Eurofins DiscoverX, in conjunction with Drug Target Review, sponsored and moderated a Bioassay roundtable discussion webinar with group leaders from…

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Brochures & Flyers Cell Banks for Bioassays

Ensuring Long-Term Assay Reproducibility for Critical Reagents

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Brochures & Flyers Eurofins DiscoverX – Delivering Solutions from Discovery to Market

Products & Custom Development Capabilities.

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Bioassays for Biologics

Ready-to-use kits for biologics characterization, MOA confirmation, NAbs detection, stability studies, & potency testing

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CDMO/CRO Certification Program for Cell-Based Assays

Program designed to qualify CRO/CDMOs to run Eurofins DiscoverX bioassays for client downstream therapeutic efforts

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Potency and QC Lot-Release Testing Solutions

Providing functional, MOA-based bioassays with superior lot-to-lot reproducibility

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