Plasmids release specifications are critical to the manufacture of many cell and gene therapy (CGT) products, but current regulatory guidance is limited in defining expectations for the release of plasmids as a starting material. BioPhorum has been highly active in this area and its most recent paper BioPhorum raw materials: cell and gene therapy critical starting material – further discussion on plasmids to establish release specifications...
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Discussion on plasmids to establish release specifications using a risk-based approach to manage supply
This paper shares industry feedback after the publication of two BioPhorum papers that complement ongoing efforts in the wider CGT field. It supplements these publications by delving into identity testing and cross-contamination for plasmid master cell banks and plasmid DNA, and other plasmid DNA release tests (including DNA homogeneity, residual DNA and host RNA, and sterility or bioburden).
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...
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.