Ensuring Quality Oversight In Plasmid DNA Manufacturing

By Katya McLane, Ph.D., director of process science, and Ron Chantung, director of drug substance, Ajinomoto Bio-Pharma Services

The landscape of today’s biopharmaceutical industry is changing rapidly with the introduction of novel drug products, such as personalized medicines. However, while this sector of the market is expected to have a major impact on patient care in the coming years, it also presents significant challenges during development and manufacturing. One such area is a gap in GMP-quality plasmid DNA (pDNA) supply, an essential building block for viral vector and even mRNA-based vaccines and therapies ― the latter seeing intensified focus since the success of the COVID-19 vaccines. Most notably is the limited number of CDMOs with the capacity and expertise to provide GMP-quality pDNA at the volumes needed to meet clinical and commercial manufacturing demand, leading to long lead times for companies waiting for this critical raw material.

While there is a growing number of CDMOs entering this increasingly competitive market, it is important to understand the challenges associated with manufacturing pDNA, so you can ensure the partner you select is able to provide high-quality materials for the lifetime of your product.