Ensuring Quality Oversight in Plasmid DNA Manufacturing

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.

Finding a CDMO partner capable of meeting both pre-clinical and commercial manufacturing needs can be a difficult proposition. A dearth of suppliers and lack of external capacity, coupled with a growing need for gene therapy products and a burgeoning market, have served to limit the number of players with the track record for plasmid production. Ajinomoto Bio-Pharma Services, with a global footprint and more than 40 years of CDMO experience, possesses the infrastructure to meet clients’ plasmid production needs. In San Diego, Aji Bio-Pharma has facilities that possess capabilities in drug substance, drug product filling, and high-potency antibody drug conjugate services. Its sister locations, scattered across the world, boast unique services – at its Belgium site, the company produces small molecule products and API for both clinical and commercial partners. India also is home to a small molecule manufacturing site. At its two sites in Japan, Ajinomoto employs its AJIPHASE® technology to produce pure peptides and oligonucleotides – short, synthetic strands of DNA or RNA with a broad set of applications in pharmaceutical development. The AJIPHASE process uses fewer solvents and reagents, resulting in cost savings for clients. In San Diego, Aji Bio-Pharma’s drug substance business segment has two primary facilities, with dedicated utility yards that provide USP, water for injection (WFI), oxygen, clean compressed air, plant steam, chilled water, and nitrogen into its suites. Each suite also has a dedicated air handler unit, which enables multi-campaign production activities. Its suites are ISO-7 and ISO-8 rated, sanitized on a weekly basis, and the campus’ quality control team performs weekly environmental monitoring to ensure a state of control. The San Diego site is a microbial cell host production facility, specializing in producing biologics from E. coli and yeast, as well as employing its proprietary CORYNEX protein expression system.