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.
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
| Clone | Master Cell Bank (MSB) | Working Cell Bank (WCB) | Bioassay Cells |
|---|---|---|---|
| Cell Line Identity & Purity | Functional Performance | Functional Performance | Functional Performance Bioassay QC |
| Passage Stability | Passage Stability | Sterility & Mycoplasma Testing | Sterility & Mycoplasma Testing |
| Sterility & Mycoplasma Testing | Sterility & Mycoplasma Testing |
Cell Banks for Bioassays Project Process and Deliverables
Learn how to confidently de-risk your biologics’ lot-release strategy by establishing a dedicated analytical cell banks for your bioassay. Find…
Watch NowEurofins DiscoverX, in conjunction with Drug Target Review, sponsored and moderated a Bioassay roundtable discussion webinar with group leaders from…
Read MoreEnsuring Long-Term Assay Reproducibility for Critical Reagents
Read MoreProducts & Custom Development Capabilities.
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Ready-to-use kits for biologics characterization, MOA confirmation, NAbs detection, stability studies, & potency testing
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Program designed to qualify CRO/CDMOs to run Eurofins DiscoverX bioassays for client downstream therapeutic efforts
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Providing functional, MOA-based bioassays with superior lot-to-lot reproducibility
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