Plasmid DNA cGMP Production: Finding The Right Manufacturing Partner

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

The increased demand for plasmids for targeted gene therapeutic delivery will require creative solutions to maximize the commercial potential of these therapies. Partnering with a CDMO equipped with the quality oversight, capacity, expertise, and equipment for plasmid DNA production is critical to ensuring a stable therapeutic supply.

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, has 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.