Under a Technology License Agreement with the Houston Methodist Research Institute, Contract Developer and Manufacturer VGXI Achieves Key Milestones with Establishment of Pilot Production Capabilities for RNA-Based Medicines.
The Woodlands, TX – VGXI announces successful implementation of new RNA production services through completion of all Phase II initiatives as part of a license agreement with the Houston Methodist Research Institute. The company has established pilot mRNA manufacturing capabilities in a purpose built GMP production suite at its current facility in The Woodlands, Texas. A full range of capabilities have been developed to support client projects from initial plasmid DNA construction through linearization, in vitro translation, mRNA purification, and comprehensive quality control testing. VGXI will continue close collaborations with the Research Institute RNACore as it proceeds into the final phase of the agreement with process scale-up and optimization for large-scale GMP mRNA production services. Launch of clinical grade mRNA manufacturing is anticipated in 2020.
mRNA therapeutics are rapidly advancing in the clinic with a range of potential applications from gene therapies and gene editing to RNA-based vaccines. According to VGXI’s CEO Young Park, “We are building on nearly 20 years of plasmid DNA manufacturing experience, making VGXI ideally poised to provide industry-leading solutions for high purity RNA production and testing.” Contact VGXI today to learn more.
ABOUT VGXI, INC.
VGXI, Inc. is a leading provider of manufacturing and development services for DNA vaccines and gene therapies. The company has a reputation of success in manufacturing DNA products under cGMP conditions for clinical trials in the US, EU, Asia, Canada, and Australia, and its cGMP and non-GMP products have passed rigorous reviews by several international regulatory agencies. VGXI’s ability to work with unique requirements and create custom manufacturing solutions is based on its patented manufacturing process, flexible cGMP production facility, and experienced development team. VGXI, Inc. is a wholly-owned subsidiary CDMO of GeneOne Life Science, Inc. To learn more or request a quote, visit http://www.vgxii.com.
ABOUT GENEONE LIFE SCIENCE
GeneOne Life Science Inc. (“GeneOne” KOSPI: 011000) is an international DNA vaccine and product developer and leading contract manufacturer of DNA plasmid-based agents for pre-clinical and clinical trials for global companies and institutions. It researches and develops DNA vaccines and products to prevent and treat incurable diseases in South Korea and internationally. The company is headquartered in Seoul, South Korea. VGXI, Inc., GeneOne’s wholly-owned manufacturing subsidiary located in Texas, is the largest pure-play cGMP DNA plasmid manufacturing facility in the world. For more information, visit http://www.genels.com/en.
ABOUT HOUSTON METHODIST
Houston Methodist comprises a leading academic medical center and seven community hospitals serving the Greater Houston area. Houston Methodist‘s academic medical center includes the flagship hospital and the Houston Methodist Research Institute, located in the heart of the Texas Medical Center, the largest medical center in the world. Houston Methodist Hospital is ranked as one of the nation’s top 20 hospitals and the #1 hospital in Texas by U.S. News & World Report.
The RNAcore at the Houston Methodist Research Institute, directed by professor and chair, John Cooke, M.D., Ph.D. is a leader in RNA synthesis and generates both research and clinical grade RNA constructs including mRNA, modified mRNA (mmRNA), microRNA cassettes, and noncoding RNA. In addition to manufacturing methods, the RNAcore has also developed technologies for improved stability of RNA products and enhanced delivery of nucleic acid based therapies. Beginning as a core group for the Progenitor Cell Biology Consortium of the National Heart, Lung, and Blood Institute, the RNAcore is now also supported by the Cancer Prevention Research Institute of Texas, to further the development of cutting-edge RNA technologies. For more information, visit www.houstonmethodist.org/RNAcore.
CAUTIONARY FACTORS THAT MAY AFFECT FUTURE RESULTS
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Christy Franco, PhD
Sr. Manager, Business Development