This partnership is ideally suited to meet the growing industry need for DNA pharmaceuticals.
The Woodlands, TX USA (PRWEB) February 12, 2015
VGXI, Inc., a contract manufacturing organization specializing in GMP plasmid DNA production, announces today that they have entered into a partnership and licensing agreement with a commercial scale manufacturer for GMP plasmid production. According to the agreement, the partnering company will incorporate VGXI’s proprietary plasmid manufacturing and purification technologies for production of DNA-based pharmaceuticals at Phase III to commercial-scale. Technology transfer is already underway and large-scale GMP plasmid production will be available as soon as this process is complete.
“We are extremely pleased to be able to offer this new capability to all of our current and prospective customers” said VGXI CEO, Young Park. “Several clients have expressed a need for increased production volumes, and this partnership will allow commercial scalability until VGXI has established its own large-scale manufacturing facility.”
The gene therapy and DNA vaccine industries have experienced dramatic growth in just the past year, with renewed investment from large pharmaceutical companies, record-breaking IPOs, and recent clinical successes for cancer immunotherapies and next-generation genetic vaccines. As these technologies mature into larger, later-stage clinical trials, it will be critical for the supporting manufacturing industry to keep pace while maintaining consistency in the production process and without sacrificing the quality or purity of the DNA product.
This partnership is ideally suited to meet the growing industry need for DNA pharmaceuticals. Supplying cGMP plasmid products for clients worldwide, VGXI has developed extensive manufacturing expertise and has been repeatedly recognized by the industry for the quality of its CMO services and DNA products. The Texas-based organization has already demonstrated reliable scalability of its patented AIRMIX™ lysis technology across fermentation capacities from 10L to 500L volume. Through the license agreement, the AIRMIX™ continuous, low-shear cell disruption technology as well as other highly optimized manufacturing techniques will be transferred and further scaled to fermentation capacities of up to 1500L at the European-based plant. As one of the most modern facilities, this plant was purposely designed for biologics manufacturing and is well-suited for commercial scale-up of the VGXI process.
By combining the complementary capabilities of both companies, the strategic partnership announced today will provide the biopharmaceutical industry with a unified DNA manufacturing solution and enable further clinical development of genetic vaccines and therapeutics.
ABOUT VGXI, INC.
With over 15 years of experience, VGXI Inc. is a leading provider of plasmid DNA manufacturing and development services for DNA vaccine and gene therapy research. The company has an outstanding track record of success in manufacturing plasmid products under GMP conditions for clinical trials in the US, EU, Asia 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 is a wholly- owned subsidiary of GeneOne Life Science, Inc. (KRX:011000)
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