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
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.
Analytical Cell Banks for Bioassay Production Workflow
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.
Custom Cell Scale-up and Production
Eurofins DiscoverX offers tailored solutions for custom scale-up of cells to meet the diverse needs of clients. Our expertise and scale-up capabilities enable researchers to accelerate their development programs and ultimately bring innovative treatments to market more efficiently and effectively. This scale-up capability allows for manufacturing of customized cell lots for Eurofins DiscoverX or non-DiscoverX cell lines and caters to the unique requirements of each client.
Typical custom cell scale-up project steps:
- Assessment of Analytical Requirements: The cell banking team works with you to assess your program needs including factors such as cell type, application, desired performance criteria, production goals, and regulatory considerations.
- Design of Scale-up Strategy: Based on the analytical requirements, a customized scale-up strategy is designed to meet the client’s needs. This includes determining the optimal cell culture conditions to maximize cell yield and maintain cellular characteristics relevant to the analytical assays.
- Execution of Scale-up Process: The scale-up process is executed according to the tailored strategy with careful attention to maintaining the integrity and quality of the cell population.
- Quality Control and Assurance: Throughout the scale-up process, rigorous quality control measures are implemented to ensure the consistency, purity, and viability of the expanded cell population.
- Delivery of Customized Lot: Once the scale-up process is complete, the expanded cell population is harvested, cryopreserved, and testing. Analytical techniques such as cell counting, viability assays, flow cytometry, and functional assays may be used to assess cell characteristics and performance. The lot is then released upon meeting the specifications as agreed during the assessment stage.
Examples of Customized Cell Scale-up Production Options
Characterization and Testing of Cells
All source cell lines are tested for identity, clonality, purity, and passage stability as well as certified to be mycoplasma-free. Manufacturing of all cell banks and custom scale-up cell production lots are completed from these certified cell lines, and a Certificate of Analysis is provided upon QC release of cell banks.
| Testing* | Clone | Master Cell Bank | Working Cell Bank | Bioassay Cells | Custom Lot Production |
|---|---|---|---|---|---|
| Functional Performance | ✔ | ✔ | ✔ | ✔ (Bioassay QC criteria) | ✔ |
| Sterility & Mycoplasma Testing | ✔ | ✔ | ✔ | ✔ | ✔ |
| Passage Stability | ✔ | ✔ | ✔ Optional | ||
| Identity & Purity | ✔ |
Cell Banks for Bioassays Project Process and Deliverables
A similar milestone-based approach is used to generate cell banks for research-grade producer cell banks, and customized lot production.
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