Cell Bank Establishment

The establishment of cell banks represents the first GMP element in the life cycle and production chain of a biologic product. The standardized preparation of cell lines is important to ensure the quality and safety of biologics during commercial production. The first key step in this process is the establishment of a master cell bank (MCB) and working cell bank (WCB). Creative Biogene offers complete cell banking services for GMP production (master cell bank, working cell bank) and end-of-production cell banks upon request. Our production adheres to ICH Q5 quality guidelines and all GMP production cell banks are performed and cultured in our Animal Origin Free (AOF) and non-Animal Origin Free cleanrooms designed to ensure quality and consistency throughout the production lifecycle of biologics.

Cell Bank Establishment-1

Why Cell Banking is Important?

During GMP cell manufacturing, cells must undergo multiple passages in culture, which increases the risk of genetic modification, contamination, or loss of expressed structures during cell division. Therefore, cells must undergo as few passages as possible for optimal drug production, and the original high-yield clones are not lost or altered. The establishment of cell banks provides a characterized common starting source for each GMP manufacturing batch and ensures a consistent supply of raw materials/cell substrates throughout the life cycle of the biopharmaceutical product and beyond.

Master Cell Bank (MCB)

MCB is defined as an aliquot of a single cell pool, usually prepared from selected cell clones under specific conditions, dispensed into multiple containers, and stored under specific conditions. MCB is used to export all working cell banks (WCB).

Creative Biogene's Master Cell Banks (MCBs) are derived from uniparental cell cultures. MCBs are produced using standardized laboratory procedures and are tested for purity, identity, content, activity and viral safety in animal cells to ensure proper identity and to certify that the cell banks are free of accidental contamination.

Working Cell Bank (WCB)

WCB was prepared from aliquots of cell homogenate suspensions obtained by culturing MCB under defined culture conditions. Creative Biogene's Working Cell Banks (WCBs) are prepared from one or more MCB sample vials and are used in production prior to testing similar to MCB to characterize the composition in terms of purity, identity and content/concentration.

Our Capabilities

GMP production for master and working cell banks (MCB and WCB) of prokaryotes and eukaryotes (e.g., bacterial, yeast, fungal, and mammalian cell lines) in compliance with ICH Q5D standards.
Quantity of MCB or WCB vials: up to 300.
Proprietary GMP production facilities, Grade A/B cell banking suites (AOF level) and ISO5/7 clean rooms (both non-AOF).
GMP-compliant MCB and WCB are preserved in individual cryotubes and stored in ultra-low temperatures (< -150 °C) in the gas phase of liquid nitrogen.
Complete characterization and biosafety testing.

Creative Bogene's cell banking experts have over a decade of experience. Our cell banking capabilities and comprehensive characterization services provide you with a single-source solution for all your cell line demands. Please feel free to contact us if you have a need, and our experienced specialists will be happy to assist you.

* For research use only. Not intended for any clinical use.

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