Microbial cell bank plays a key role in the production of biologics, such as vaccines, therapeutic proteins, peptides, enzymes, antibody fragments, and plasmid DNA (pDNA). It ensures a consistent and reliable supply of well-characterized microbial strains throughout the product lifecycle.
Based on the regulatory guidelines, the Master Cell Bank (MCB) and Working Cell Bank (WCB) are generated under GMP conditions. The microbial cell banks should be fully characterized following The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines (ICH Q5 Parts A, B, and D).
Keywords: microbial bank preparation, cell bank preparation, cell bank production, primary cell bank, master cell bank, working cell bank, strain bank establishment, microbial strain cell banking, microbial strain libraries, microorganism bank, bacteria bank, fungal bank, yeast bank, strain storage
Application: human medicine production, animal medicine manufacturing, vaccine manufacturing, synthetic biology, recombinant large molecule biologics production, recombinant biologics manufacturing, biological reagent production
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