A science based approach to qualifying replenishment working cell banks, an industry view

Cell banks represent the fundamental starting substrates for biological drug substance (DS)/drug substance intermediate (DSi) manufacturing. Therefore, the availability of well-characterized cell banks capable of supporting manufacturing processes is imperative to ensure uninterrupted drug product supply to patients and global markets.

To this end, two-tier cell banking systems are developed, consisting of master cell banks (MCBs) and working cell banks (WCBs). Typically, WCBs are derived from the MCB to preserve the long-term integrity of the MCB. Although WCB inventories (e.g. vials, ampoules, bags) are generally developed in plentiful supply, over time it is necessary to replenish WCB inventories to meet product demand.

Recent experience shows that regulatory requirements for introducing replenishment WCBs in many countries are highly variable in terms of requirements for supporting data and reporting categories. This results in inconsistent expectations among different health authorities.

This paper examines the scenarios under which replenishment WCBs are manufactured, including when they are replenished and introduced according to the initially registered process (‘like-for-like’ replenishment). It highlights several changes to cell bank manufacturing and materials that can occur when WCBs are replenished.

Its goal is to ensure a consistent cross-industry expectation for an acceptable replenishment WCB qualification strategy using a risk-based scientific approach, considering the potential impact on cell bank growth, viability performance and product quality.

There are few circumstances where replenishing a WCB is likely to impact the phenotype of the WCB or quality of the DS/DSi. Even when changes are necessary to either the cell banking process, cell bank materials or location of cell bank manufacture, the risk of not meeting criteria for qualification (e.g. KPIs) is low for replenishment WCBs.

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A risk-based scientific approach to qualify replenishment working cell banks, an industry view November 2021.pdf
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  • Create Date 30th November 2021
  • DOI https://doi.org/10.46220/2021DS005
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