Addressing quality standards of plasmid DNA
This infographic outlines the challenges related to inconsistent quality control of plasmid DNA, particularly when used as the starting material in cell and gene therapy products. It emphasizes the necessity for commercially available plasmid standards such as physical reference materials, which serve as benchmarks during cell and gene therapy manufacturing, as well as documentary outlines. Additionally, it highlights how the development of an analytical guide may help manufacturers enhance the quality standards for plasmid-based products, including gene therapies.
This infographic is part of the RegMedNet Spotlight on gene therapy analytical testing, in association with US Pharmacopeia.
RMN – 2025 – Q2 Spotlight – GT – USP – infographic_V3_compressed
Illustrated by Tobias Dumbraveanu (Taylor & Francis Group, London, UK).