Specializing in cGMP Plasmid Manufacturing
VGXI, Inc. is a leading contract manufacturer of plasmid DNA. We deliver flexibility, experience, reliability and value to our clients’ challenging programs. The company’s cGMP and non-cGMP products have passed rigorous international regulatory reviews. VGXI’s patented manufacturing process and cGMP production facilities give us the ability to work with unique project requirements. The unsurpassed knowledge and ingenuity of our team can be leveraged to create a custom manufacturing solution for the benefit of your organization.
VGXI will build a solid foundation for your program with our DNA plasmid production services. We manufacture QUALITY DNA plasmids across a range of service levels:
- cGMP DNA plasmids for clinical through commercial supply
- Highly Documented (HD) DNA plasmids for virus production and toxicology studies
- High purity plasmid DNA preparations for pre-clinical research
The VGXI manufacturing staff is comprised of experts in Process Development, Quality Control, Quality Assurance and Validation of plasmid-based biopharmaceuticals. Finally, VGXI has an outstanding track record of success in manufacturing challenging plasmid products under cGMP conditions with exceptional yield, quality and prompt delivery. We supply DNA plasmids worldwide for clinical studies and comply with multiple regulatory agencies.
History
VGXI was founded around technology for optimized, large scale plasmid DNA purification. The company has nearly 20 years of experience manufacturing GMP products for use in human clinical trials.
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1997
ADVISYS, Inc., was founded as a gene therapy company
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2001
Offices opened at the current location in The Woodlands, TX
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2003
Manufacturing of the first clinical FDA trial batch was completed
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2004
The company transitioned to a Contract Manufacturing Organization (CMO)
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2008
The company was acquired by GeneOne Life Science, Inc. and all manufacturing activities were aligned into VGXI, Inc.
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2010
VGXI completed an expansion of its GMP manufacturing facility in The Woodlands.
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2012
VGXI launched its Highly Documented (HD) plasmid manufacturing service to supply raw material for GMP virus and cell therapy production
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2012
VGXI entered a licensing agreement with Nature Technology Corporation to offer antibiotic-free HyperGRO™ fermentation technology for cGMP plasmid production
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2015
VGXI celebrated the opening of the Advanced Biopharmaceuticals International Center of Support (ABICS) at their facility in The Woodlands, TX
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2016
VGXI celebrated the grand opening of the Small Scale GMP production plant
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2018
VGXI celebrated the grand opening of the Flex Scale GMP Production Plant
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2020
VGXI breaks ground for New Heaquarters and Manufacturing Facility in Conroe, TX