Cell Bank Establishment & Testing - US edition MasterClass

The Master Cell Bank (MCB) is not only the starting point of GMPs (in accordance with ICH Q11) but it is also the starting point of the manufacturing process of therapeutical recombinant proteins and gene therapy products.

24-25 October, 2023, Virtual

Time Zone: Eastern Standard Time (EST) / UTC−05:00

Overview

The Master Cell Bank (MCB) is not only the starting point of GMPs (in accordance with ICH Q11) but it is also the starting point of the manufacturing process of therapeutical recombinant proteins and gene therapy products. The MCB is one element of the cell bank system which comprises also the Working Cell Banks (WCB) and the End-of-Production Cell Bank (EoPCB). The Master Class will also address potential issues encountered when establishing cell banks and will discuss operational aspects for ensuring good quality cell banks.

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RECOMMENDATION

Who should attend?

• Process development scientists and managers

• CMC development program managers

• Manufacturing managers and operators

• Quality Assurance representatives

• Regulatory Affairs representatives