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.
- 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
Cell Banks for Bioassays Project Process and Deliverables
Eurofins DiscoverX, in conjunction with Drug Target Review, sponsored and moderated a Bioassay roundtable discussion webinar with group leaders from…Read More
Program designed to qualify CRO/CDMOs to run Eurofins DiscoverX bioassays for client downstream therapeutic effortsRead More