Consider Eurofins DiscoverX’s custom development capabilities for custom cell lines, assays, & enzyme development.
Cell Banking & Customized Scale-up Cell Production Capabilities
Ensure Long-term Critical Reagents Supply and Assay Reproducibility
Cell banking plays a crucial role in supporting the development of therapeutics and involves the preservation and storage of cells, tissues, or cell lines that serve as repositories of valuable biological resources. Cell banks provide researchers with consistent and reliable cell populations for a myriad of applications from drug discovery to QC lot-release, including high-throughput screening, preclinical studies, lot release testing, and therapeutic manufacturing.
Complementing cell banking, Eurofins DiscoverX® offers custom scale-up cell production capabilities catering to the specialized needs of drug developers and biotechnology companies by facilitating the transition from laboratory-scale cell cultures to large-scale production. Through meticulous process optimizations and robust manufacturing, custom scale-up enables efficient and scalable production of cells for diverse applications.
Confidently de-risk your drug development programs by establishing dedicated cell banks with Eurofins DiscoverX.
Product Highlights
- Customized Production – Ready-to-use cell vial lots manufactured as per your program requirements
- Extensively Tested – Well-characterized & 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
Cell Banking
Custom Lot Production
Characterization & Testing
Process & Deliverables
Resources
Related Pages
Cell Banking
Cell banking is an essential practice in biotechnology regenerative medicine and biomedical research that involves the preservation and storage of cells, tissues, or cell lines under controlled conditions for future use. Cell banking is a critical aspect for both therapeutic producer cell lines (called Producer Cell Bank) as well as cells used as analytical reagents (called Analytical Cell Bank). Generating an analytical cell bank ensures the availability of well-characterized and genetically stable cell populations for (1) discovery to preclinical studies, minimizing variability between experiments, ensuring the reliability and validity of experimental results, and (2) lot-release applications, such as potency testing, ensuring long-term assay reproducibility and supply assurance. Cell banking also plays a vital role in supporting regulatory compliance by providing documentation of cell line authentication, characterization, and handling procedures for the critical reagents used, thereby demonstrating the reproducibility and reliability of preclinical findings.
Advantages of Establishing a Dedicated Analytical Cell Bank
- Ensuring reproducibility
- Speeding up drug development
- Ensuring continuity
- Cost savings
- Scalability
- Regulatory Compliance & Quality Assurance
Eurofins DiscoverX offers cell banking as a 2-tiered cell bank, which refers to a structured approach that involves the creation and maintenance of two distinct levels of cell banks: the Master Cell Bank (MCB) and the Working Cell Bank (WCB).
Master Cell Bank (MCB): The MCB represents the primary level of cell banking and serves as the foundational source of cells for downstream applications. Cells within the MCB are derived from a single vial or passage and undergo extensive characterization and testing to ensure their genetic stability, identity, and suitability for further use. The MCB is typically generated and maintained under strict quality control measures. Cells from the MCB are used to establish the Working Cell Bank (WCB) and serve as the reference standard for all subsequent cell-based experiments and production activities.
Working Cell Bank (WCB): The WCB represents the secondary level of cell banking and serves as the immediate source of cells for further production for large lots that are then used for routine experimentation. Cells within the WCB are derived from the MCB and undergoes periodic replenishment from the MCB to ensure a continuous and sustainable supply. While cells within the WCB may undergo additional testing and quality control measures, they are generally considered to be representative of the cells within the MCB and are used interchangeably for experimental purposes.
For manufacturing a single tiered bank, a WCB is produced directly from the source clone lot and used as source of cells for manufacturing the large production lots.
Establishing a well-characterized cell bank follows a systematic approach from expansion of source clone cells to testing and cryopreservation under strict quality control measures. Eurofins DiscoverX manufactures cell banks based on your program requirements for size, tiers, testing (standard or compendial), application, etc.
Currently, Eurofins DiscoverX cell banking capabilities are available for mammalian cells and there is an option for off-site storage for WCB vials.