This paper provides a commentary on the analytical methods used for the release and/or characterization of full, partially filled, and empty capsids in various process development step and clarifies which analytical methods are amenable to GMP validation for product release in late-stage clinical trials and commercialization of gene therapy products.
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The purpose of this BioPhorum member only survey is to understand current industry best practices, understand member experience and if any of the workstream members has had regulatory success leverage prior knowledge.
A BioPhorum member only deliverable describing the work of the Plasmids subteam
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).
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.