Cell Line Development & Banking
Cell line development
The key objective of the cell line development process for therapeutic protein production, is to obtain a stable and highly productive monoclonal cell line, which produces proteins consistently meeting the quality profile expectations. High level of expertise and advanced technologies are indispensable in this area. Consequently, our highly experienced staff uses development program.
The Beacon Select System offers continuous monitoring and comprehensive documentation of the process from a single cell, facilitating the rapid confirmation of monoclonality within a single selection round. The system meets all regulatory requirements while also being the most time-efficient method available on the market. By integrating advanced knowledge with high-throughput technology, our scientists are able to evaluate the product for key attributes, that are critical for industrial applications.
Non-GMP Research Cell Banks (RCB)
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. Although the RCB is a pre-GMP cell bank, meaning that its regulatory requirements are less stringent compared to cGMP-compliant banks, RCBs are still rigorously assessed at various levels, including microbiological safety, recovery, and stability. The RCBs, like other cell banks, are stored in a dedicated system designed for biobanks, biorepositories, and LN2-based sample collections.
For RCB development, our specialists create multiple monoclonal cell lines from single clones and then select and expand the ones which best meet our Clients’ quality parameters to banked cell lines that. Parameters which are thoroughly analyzed include cell density, doubling time, and the quality features of the produced molecule.
cGMP Master Cell Banks (MCB) and cGMP Working Cell Banks (WCB)
At Mabion we offer comprehensive and fully compliant services for the preparation of cells and virus bank, including generation of MCB/WCB and MVB/WVB under cGMP conditions. The scope of the services includes generation eucaryotic cell banks. We ensure the highest standards of quality, safety, and consistency in cell bank production, supporting your biologics and cell therapy development programs from early-stage development through to commercial manufacturing.
The proper cell bank is the foundation of all future manufacturing activities and represents the initial, fully characterized population of cells that will be used for the production of your therapeutic product. Our cell bank preparation process is meticulously designed to ensure the long-term stability and integrity of the cell line, which is essential for ensuring consistent product quality throughout the lifecycle of your therapeutic.
The key steps in our cell line development and banking processes are:
Cell culture expansion
- We begin by working closely with you to understand the specific characteristics and requirements of your cell line. The selected cell population is expanded in controlled conditions.
Harvesting and cryopreservation
- Once the desired cell density and quality attributes are achieved, cells are harvested, formulated with cryoprotectants, and aliquoted into cryovials under sterile conditions. The vials are then subjected to a controlled-rate freezing process in our modern freezing system to ensure optimal cell viability upon thawing. Cryopreservation is a process where any cell metabolism which might cause damage to the biological material in question is effectively stopped. It is an effective way to transport biological samples over long distances, store samples for prolonged periods of time, and create a bank of samples for users.
Characterization and testing
- Our analytical offer also includes the conduct of growth tests of the manufactured MCB/WCB, titer verification for MBV/WVB and sterility tests for all type of banks.
Long-term storage
- The cell banks are stored in our cGMP-compliant, temperature-controlled cryochamber, which are equipped with automatic nitrogen level and temperature control systems to ensure the long-term stability and security of your cell bank.