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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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.