Increasing demand for plasmid DNA (pDNA) and increasing research and development activities are major factors driving the plasmid DNA manufacturing market growth. For instance, in April 2018, PlasmidFactory GmbH & Co. KG acquired new laboratory space to expand research and development activities and production of plasmid DNA.
Cobra Biologics, a U.K.-based contract development and manufacturing organization (CDMO) has been producing plasmid DNA for a number of clinical applications for over 15 years at an approved site in the U.K. under the European Union (EU) clinical trials directive.
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The company developed its own manufacturing process for production and purification of pDNA with related proprietary technologies, which include an antibiotic-free plasmid maintenance system, operator repressor titration (ORT), and cell-lysis technologies (2–4). Moreover, company successfully executed over 240 DNA programs with process development, manufacturing, and stability studies for over 35 different customers, globally. Generated plasmids have been used in clinical trials for gene therapy and vaccines as well as in viral vector production.
Key players in the market are focused on research & development, expansion, and collaboration activities in order to enhance their market share. For instance, in January 2019, Sarepta Therapeutics, Inc. and Aldevron announced their collaboration. This collaboration provided Sarepta with Aldevron’s manufacturing slots and capacity for production of GMP grade plasmid for its various programs related to gene therapy. For instance, in January 2019, Sarepta Therapeutics, Inc. collaborated with Aldevron to supply GMP grade plasmids, in order to cater to the demand of Sarepta’s gene therapy clinical trials and for commercial supply.
Moreover, in April 2018, PlasmidFactory GmbH & Co. KG announced the acquisition of new laboratory space to expand research and development activities and production of plasmid DNA. This strategic move was taken, owing to increasing demand for High Quality (HQ) Grade DNA production.
Key players in the market are focused on adopting strategies such as mergers and acquisitions to enhance their product portfolio. For instance, in February 2016, Agilis Biotherapeutics, LLC (Agilis) and Waisman Biomanufacturing entered into an exclusive partnership agreement for the production of Agilis’ novel gene therapy product, AGIL-FA, for the treatment of Friedreich’s ataxia (FA).
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Similarly, in March 2019, Aldevron announced expansion plan for antibody development platform facility in Germany. This expansion plan will add around 4,300 square feet of production and laboratory space to current facility.
Key players operating in the global plasmid DNA manufacturing market include Cobra Biologics and Pharmaceutical Services, VGXI, Inc., Aldevron, Kaneka Corporation, Nature Technology Corporation, PlasmidFactory GmbH & Co. KG, Cell and Gene Therapy Catapult, and Waisman Biomanufacturing
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