Raw Materials 2019

ATMP raw materials: ‘the plasmid conundrum’

Cell & Gene Therapy Insights 2019; 5(10), 1259-1265.

10.18609/cgti.2019.132

Published: 17 October 2019
Perspective
Alan Griffith

Plasmids and plasmid DNA (pDNA) have been key components in recombinant DNA molecular biology for decades. One of their uses as a precursor raw material represents a cornerstone of viral vector ATMP manufacturing. Here we provide a synopsis with regard to their own manufacturing lifecycle, limitations, demand, regulatory expectations and supply chain, as more and more companies join the gene and cell therapy clinical trial races to market in this fast-paced sector.