Discussion on plasmids to establish release specifications using a risk-based approach to manage supply

Plasmids release specifications are critical to the manufacture of many cell and gene therapy (CGT) products, but current guidance defining expectations for the release of plasmids as a starting material is limited.


To reach a consensus on test attributes and release requirements for plasmids and the bacterial master cell banks used to produce them, BioPhorum’s CGT Raw Materials Plasmids Release Specifications team collaborated to propose a platform framework to stimulate a broader industry discussion


The team’s latest output is this paper, which 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). Building on the momentum of the previous papers, consideration is also given to testing for elemental, extractable and leachable impurities, plasmid stability studies and evaluating changes to the plasmid manufacturing process. The paper also updates the previous case study risk assessment by re-evaluating risks for the supply of GMP plasmid.

The previous 2020 papers were 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 and Raw Materials: Perspectives on raw and starting materials risk assessment for cell and gene therapy (CGT) processes. 

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Further discussion on plasmids to establish release specifications using a risk-based approach to manage supply June 2022.pdf
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  • Create Date 29th June 2022
  • DOI https://doi.org/10.46220/2022CGT001
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