Addressing the Plasmid DNA Manufacturing Bottleneck
Over the past few years, we have seen a steady increase in the demand for plasmid DNA, as the gene and cell therapy industries have experienced rapid growth. This demand for plasmid DNA has caused a bottleneck, since production and supply have not been able to keep up with demand, which has been further exacerbated by the COVID-19 pandemic ¹.
The manufacture of both mRNA and DNA vaccines relies on plasmid DNA. To put this demand into perspective following the pandemic, the manufacture of one COVID-19 mRNA vaccine requires half of the world’s plasmid DNA manufacturing capacity¹.
This bottleneck has far-reaching implications for the industry, as it could slow down R&D pipelines worldwide, with many suppliers already experiencing 6 to 12 month backlogs². The process of producing plasmid DNA is inherently slow, expensive, has limited capacity, and is “prone to batch failure”¹. Several key CMOs are expanding their production capabilities by opening new facilities to help meet demand³.
What role can Purilogics play in addressing the bottleneck?
The purification process may present a problem, as there may also be bottlenecking within this process. Market demand could require the production of 100-1000 g of high-quality plasmid DNA per year for gene therapy products⁴. Mainstream purification methods rely on decades-old resin-based technologies. Resin-based purification methods are adequate for proteins, but are less than ideal for nucleic acid purification.
To avoid production delays and achieve higher cost efficiency, a new and more effective purification technology is necessary. Purilogics’ products are membrane chromatography columns that achieve purification in minutes and are perfect for nucleic acids.
Feel free to contact us at info@purilogics.com or +1 (864) 455-1457 to learn more and try it out!
References
1. Ohlson, J. Plasmid Manufacture Is the Bottleneck of the Genetic Medicine Revolution. Drug Discov Today 2020, 25 (11), 1891–1893. https://doi.org/10.1016/j.drudis.2020.09.040 .2. Tackling the plasmid supply bottleneck. https://insights.bio/immuno-oncology-insights/journal/article/1617/tackling-the-plasmid-supply-bottleneck (accessed 2022-01-17).3. DID YOU KNOW cGMP Facilities Are Expanding to Meet Worldwide Increased Demand for Plasmid DNA Production. Nature Technology. https://natx.com/cgmp-facilities-expand/ (accessed 2022-01-17).4. Hitchcock, T. Manufacturing Plasmid DNA: Ensuring Adequate Supplies for Gene and Cell Therapies. BioProcess International, 2016.