Cell Bank Establishment & Testing In-House Training

This in-house training will address potential issues encountered when establishing cell banks and will discuss operational aspects for ensuring good quality cell banks.

Overview

The  Cell Bank In-house training 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 Cell bank is one element of the cell bank system which comprises also the Working Cell Banks (WCB) and the End-of-Production Cell Bank (EoPCB).

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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