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
* 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
WCB = Working Cell Bank, QC = Quality Control