Cell Banking Services

cGMP Master Cell Banks and Master Virus Seed Stock

Master Cell Banks (MCB) and Master Virus Seed Stocks (MVSS) form the starting point for all future GMP manufacturing activities. Mabion provides generation, characterization, testing, cryopreservation, and long-term storage of eucaryotic cell banks and virus seed stocks under cGMP conditions. Properly established master banks are essential for ensuring process consistency, product quality, traceability, and regulatory compliance throughout the product lifecycle.

Our Cell Banking Services are directly connected to Cell Line Development activities. Following clone selection and establishment of a stable production cell line, the selected cell population is expanded under controlled conditions to preserve critical growth and productivity characteristics. Once target cell density and quality parameters are achieved, cells are harvested, formulated with cryoprotectants, aliquoted into cryovials under sterile conditions, and transferred into a controlled-rate freezing process designed to maximize post-thaw viability and long-term stability.

cGMP Working Cell Banks and Working Virus Seed Stock

Working Cell Banks (WCB) and Working Virus Seed Stocks (WVSS) are generated from fully characterized master banks and serve as the direct source material for routine GMP manufacturing. High-quality working banks are critical for maintaining batch-to-batch consistency, reducing operational variability, and supporting uninterrupted production campaigns across clinical and commercial Drug Substance Manufacturing.

Mabion prepares WCBs and WVSs using controlled expansion, harvesting, cryopreservation, and storage processes designed to preserve cell viability, genetic stability, and productivity. During cell culture expansion, selected cell populations are cultivated under controlled conditions to maintain required quality attributes. Following harvesting and cryoprotectant formulation, the material undergoes controlled-rate freezing to minimize cellular stress and maximize recovery after thawing.

Mabion performs characterization and testing of manufactured banks, including growth testing for MCB/WCB, titer verification for MVB/WVB, and sterility testing for all bank types. All cell banks undergo analytical characterization and microbiological testing prior to release. Final banks are stored in cGMP-compliant cryochambers equipped with automated liquid nitrogen level and temperature monitoring systems. This infrastructure supports secure storage, traceability, and reliable availability of manufacturing starting materials throughout the duration of the program.

Non-GMP Research Cell Banks

Research Cell Banks (RCB) support early-stage biologics development, clone selection, process optimization, and analytical studies prior to GMP manufacturing. For RCB preparation, our specialists create multiple monoclonal cell lines from single clones, selecting and expanding the best-performing clones to banked cell lines that best meet our Clients’ quality parameters, such as cell density, doubling time, and the quality features of the produced molecule. By leveraging the High-Throughput Screening platform, it is possible to reduce the time required to obtain a lead cell line to 10 weeks from transfection.

Although RCBs are developed outside cGMP manufacturing requirements, they are still subject to controlled preparation, microbiological assessment, recovery testing, and stability evaluation. The workflow includes expansion of selected clones under controlled conditions, harvesting, cryoprotectant formulation, sterile aliquoting, and controlled-rate freezing to preserve long-term cell viability and performance.

RCBs are stored in dedicated biobanking systems designed for secure long-term cryogenic storage of biological materials. Properly prepared research banks help reduce development risk, improve reproducibility during upstream development, and simplify transition into future GMP Cell Banking and manufacturing activities.