plasmids Archives

Survey to understand current practice for stability/shelf-life studies for plasmids

Oct 2022 | Benchmarking, Cell & Gene Therapy, Deliverable, Deliverables Report, Raw materials

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.

Cell and gene therapy critical starting material –establishing release specifications for plasmids

Oct 2022 | Cell & Gene Therapy, Conference, Deliverable, Deliverables Report, Raw Materials Sourcing

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

Jun 2022 | Cell & Gene Therapy, Deliverable, Deliverables Report, Publication, Raw Materials Program

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

Nov 2020 | Cell & Gene Therapy, Deliverable, Publication, Raw materials, Raw Materials Sourcing

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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Survey to understand current practice for stability/shelf-life studies for plasmids

Cell and gene therapy critical starting material –establishing release specifications for plasmids

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

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

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