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Advancements Of Microbiology

Article | 10-June-2019

CELL BANKS PREPARATION IN BIOPHARMACEUTICALS PRODUCTION

bank system, recombinant protein production) with reference to ICH guidelines (The International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use) adequate on individual production stages. The most important guidelines for establishing the cell bank are gathered in ICH Q5B and ICH Q5D (modified [14]). Master Cell Bank (MCB); Research Cell Bank (RCB); Working Cell Bank (WCB); ICH Q5 (Q5 – quality of biotechnological products) – guidelines referring

Agnieszka Sobolewska-Ruta, Piotr Zaleski

Postępy Mikrobiologii - Advancements of Microbiology, Volume 58 , ISSUE 1, 87–100