GMP-Source® And Phase-Appropriate Use For Early-Stage Clinical Trials

By Emma Bjorgum, director of client development, Aldevron

Biotechnology companies embarking on a new therapeutic development journey must balance numerous variables to maximize their chances of commercial success. These include critical decisions from the earliest phases regarding the quality level of manufacturing. At the core of these considerations is the need to produce materials with the requisite clinical quality attributes without incurring cost overruns that may jeopardize later stages of the product pipeline.

Established nearly two decades ago, GMP-Source^® represents a cost-effective, high-quality alternative to full cGMP production of plasmid DNA for many early-stage viral vector-based and mRNA end applications. By adopting the most salient features of cGMP manufacturing, including traceability of raw materials, document control, and product segregation, GMP-Source is a unique service capable of supporting therapeutic developers throughout early-stage clinical trials.

At Aldevron, GMP-Source manufacturing is rooted in decades of process innovation, unparalleled quality assurance, and years of experience and expertise supporting clinical and commercial phases. Employing this service early in therapeutic development allows sponsors a more agile and affordable solution for producing clinical-grade plasmid DNA, enabling them to progress through clinical trials more expeditiously.