cell banks

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How to replenish working cell banks with a risk-based scientific approach

Cell banks represent the fundamental starting substrates for biological drug substance/drug substance intermediate manufacturing. So, the availability of well-characterized cell banks capable of supporting manufacturing processes is critical for an uninterrupted drug product supply to patients and global markets.  This is why two-tier cell banking systems are developed, consisting of master cell banks and...

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

This paper introduces scientific and technical perspectives and recommendations from industry peers including cell banking technical experts and regulatory representatives from across the globe, representing over 15 pharmaceutical companies. The paper proposes a risk-based scientific approach to qualifying replenishment working cell banks (WCBs) when they are manufactured with, and without, changes. A consistent technical approach to the qualification of replenishment WCBs by incorporating risk-based analysis enables appropriate planning, nimble operations and de-risks product supply for patients by preventing possible delays when replenishing WCBs.

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Would you like to influence plasmid release specifications for CGT?

Plasmids release specifications are critical to the manufacture of many cell and gene therapy products. These specifications exist, but there is unlikely to be alignment between different companies. What is needed is a common language and the ability to reference a shared platform that will increase the confidence, speed and efficacy of data gathering and collaborations. The platform should also help shape future guidelines and regulations...

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Raw materials: Cell and gene therapy critical starting material: a discussion to help establish release specifications for plasmids and the bacterial master cell banks used to produce them

BioPhorum Cell and Gene Therapy is asking for your help – and is giving you the opportunity to have a say in a scientific community discussion that will influence its suggested testing practices for plasmid release specifications. The team is proposing a platform framework for testing plasmid master cell banks and plasmid DNA. 

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Making and moving operational cell banks

Moving the site of manufacture for commercial cell banks, microbial or mammalian, the renewal of working cell banks for commercial products, or making minor changes to cell banking processes is becoming more onerous from a regulatory perspective and does not have a consistent harmonized approach even within a single regulatory body such as the FDA. In the past analytical comparability of cell banks was acceptable and this changed to requiring...

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