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Plasmid DNA (pDNA) is a critical raw material for the manufacture of cell and gene therapies. As this market continues to grow, so too does the demand for high-quality pDNA.
Plasmid DNA (pDNA) is an extrachromosomal, covalently closed circular nucleic acid molecule. This molecule is used widely by bacteria to carry genes that confer different properties and replicates independently of chromosomal replication. Plasmid DNA has already found extensive use in molecular microbiology, where it can be used as a tool to transport genetic information. Additionally, pDNA has the further advantage of being easy to manipulate, enabling the production of different molecules in a range of host organisms, from prokaryotes to eukaryotes.
The discovery of plasmids in the 1950s was the starting point for subsequent advances in molecular biology, ultimately leading to the cell and gene therapy products that are now reaching the market. These have allowed patients to be treated for, and sometimes cured of, a wide range of diseases, where previously, no therapeutic options were available. Without plasmids, many of the significant advances that have been made in genetic engineering in recent times would not have been possible.
Over the years, many different uses have emerged for plasmids. A good example is the production of the first recombinant protein treatment, insulin, which had its initial FDA approval in the early 1980s. This led to clinical trials of the first viral vectors in the 1990s, and in the subsequent decade, the first clinical trials on messenger RNA (mRNA) products.
Since then, plasmids have underpinned the development of numerous other therapeutic modalities. They have applications in both lentivirus (LV) and adeno-associated virus viral (AAV) vectors, as well as mRNA and plasmid-containing nanoparticles, in addition to immunotherapy and vaccine products, shaping the research of many modern, ground-breaking therapies.
Nuria Gomez Santos, PhD, director, Process and Analytical Development—pDNA, Catalent Cell, Gene & Protein Therapies, and Barry J. Oliver, vice president, Quality, Catalent Cell, Gene & Protein Therapies.
eBook: Emerging Therapies
When referring to this article, please cite it as Gomez Santos, N.; Oliver, B.J. Plasmid DNA—The Versatile Building Block. BioPharm International’s Emerging Therapies eBook (September 2023).