Synthetic DNA: Breaking the bottleneck in genetic medicine manufacturing

Genetic medicines like mRNA vaccines, gene therapies, and gene editing are advancing rapidly, but their production is often slowed by the limitations of plasmid DNA (pDNA). Made via bacterial fermentation, pDNA manufacturing is often slow, complex, and can introduce safety and regulatory concerns due to contaminants like endotoxins and antibiotic-resistance genes. As demand increases, delays and capacity shortages have made pDNA a major bottleneck in advancing therapies.

This Innovations in Pharmaceutical Technology article reviews how synthetic DNA, produced through enzymatic, cell-free methods, offers a faster, cleaner, and more scalable alternative. Early adopters like HelixNano are using it to speed clinical progress and reduce risk. Synthetic DNA avoids bacterial contaminants, simplifies workflows, and improves consistency. With regulatory familiarity growing and clear advantages in speed and safety, synthetic DNA is poised to become the new standard in genetic medicine manufacturing.