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8 BioPharm International ® Emerging Therapies eBook September 2023 www.biopharminternational.com P lasmid DNA (pDNA) is an extrachromo- somal, covalently closed circular nucleic acid molecule. This molecule is used widely by bacteria to carry genes that confer dif- ferent 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 discover y of plasmids in the 1950s was the starting point for subsequent advances in molecu- lar 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 develop- ment of numerous other therapeutic modalities. They have applications in both lentivirus (LV) and adeno-as- sociated 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. Plasmid DNA in gene delivery Broadly speaking, plasmids can be used to deliver therapeutic genes to cells. Some plasmid deliver y Plasmid DNA—The Versatile Building Block Nuria Gomez Santos, PhD, director, Process and Analytical Development—pDNA, Catalent Cell, Gene & Protein Therapies Barry J. Oliver, vice president, Quality, Catalent Cell, Gene & Protein Therapies. 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. LOVE EMPLOYEE - STOCK.ADOBE.COM