![]() When considering the plasmids needed for the design and development of new expression systems for different recombinant proteins, only very small amounts of plasmid are required. Each plasmid template may give rise to several hundred copies of mRNA, meaning smaller volumes of plasmid could generate larger quantities of mRNA molecules. The emerging fields of mRNA-based vaccines and therapies require a plasmid as a template for the enzymatic in vitro transcription reaction. It is not uncommon for each viral vector to require up to three or four different plasmids – not including the plasmid containing the gene of interest – to develop a functional viral vector. Quantity is not the only consideration – today, the field of gene and cell therapy requires not only large quantities of plasmids but also several different plasmids for each cell transfection. If they achieve high success on the market, this may potentially drive the need for significant volumes of plasmids, as for this type of application the plasmid is the API, and purity requirements are therefore extremely high. It is important to note that DNA vaccines are still in the early stages of development. Requires volumes and quality of plasmids vary greatly depending on application area ( Figure 1 Scale and amount of plasmid needed by application area, arranged from largest to smallest required volumes (L-R).). For so-called DNA vaccines, GMP-grade plasmids is the active pharmaceutical ingredient (API).Īlthough plasmids are a common denominator within the cell and gene therapy industry, plasmids themselves are not one-size-fits-all, and one plasmid process cannot fit all needs within the industry. In order to develop mRNA-based therapies and vaccines, plasmids are used as templates for the enzymatic production of mRNA. In both cell and gene therapy, plasmids are used to transfect cell lines to produce different viral vectors of interest. The entire biopharmaceutical industry has been built on the invention of recombinant DNA technology, which requires plasmids for the development of new expression systems. They are used as a platform for many approaches found in laboratories around the globe. ![]() Plasmids are of key importance to the cell and gene therapy industry, and represent the starting point for many different modalities. As of 2020, the global plasmid market represents more than $80 million per year, and is growing at a rate of over 15% per year. Driven by new modalities, growth and market interest in plasmids has increased significantly in the last few years. Supercoiled plasmids in the size range of 5–20 kbp are of key interest to the biotechnology industry, and are most commonly used in bioprocess applications. Plasmids come in many different shapes, forms, and sizes. GMP-grade plasmids can also be used for in vivo applications such as DNA vaccines and gene therapy. Within the field of biotechnology, plasmids are predominantly of interest as vectors that can be used as tools to clone, amplify, and express genes. They are carriers of genetic information, enable functions including communication between cells, and provide properties such as resistance to antibiotics. Plasmids are a natural part of many cells, and are comprised of small extrachromosomal plasmid DNA (pDNA) molecules.
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