Assessing pDNA Purity for Cell & Gene Therapies

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Featuring Pharmatech Associates’ expertise, Brian Glass’ new article “Assessing pDNA Purity for Cell & Gene Therapies” has published in three online magazines: Cell & Gene, BioProcess Online, and Outsourced Pharma.

Brian’s article gives a framework for applying development principles of small molecules to large molecules and refers to USP’s proposed chapter <1040>. The goal of this general chapter is to describe considerations for the manufacture and release of plasmids for use as starting materials in the manufacture of cell and gene therapy drug products.

Because plasmid DNA suppliers have been taking different approaches to manufacturing and applying different specifications, Brian Glass of Pharmatech Associates takes a closer look at ways to assist manufacturers of gene therapy drug substances and drug products in building a control strategy for the plasmid DNA used as a starting material.

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Assessing pDNA Purity For Cell Gene Therapies (
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