VGXI Completes Successful FDA Inspection Enabling Client BLA Approval Milestone, Advancing Its Leadership in Plasmid DNA Manufacturing

CONROE, Texas, May 13, 2025 /PRNewswire/ -- VGXI, Inc., a leading contract development and manufacturing organization (CDMO) specializing in plasmid DNA biopharmaceuticals, including for use in gene therapies, DNA vaccines, and RNA medicines, proudly announces it has recently completed a successful inspection by the US FDA at its GMP manufacturing facility, resulting in the approval of the client's Biologics License Application (BLA). This milestone reinforces VGXI's long-standing commitment to regulatory excellence, product quality, and client success in bringing novel therapies to market.

Building upon over two decades of experience, the successful regulatory inspection recognizes VGXI's robust quality systems and proven capabilities in manufacturing plasmid DNA utilized in the development and commercialization of cell and gene therapies. As VGXI's third commercial phase program since 2019, it highlights the CDMO's history of supporting marketed products and meeting rigorous global regulatory standards. With this achievement, VGXI continues to set the benchmark for reliability and innovation in plasmid DNA manufacturing.

Young Park, CEO of VGXI, stated, "This FDA inspection is not just a validation of our facility — it is a testament to our team's unwavering commitment to quality and our partners. Our clients trust us with their most promising programs, and this milestone enhances our ability to help them accelerate timelines, reduce regulatory risk, and bring life-changing medicines to patients faster."

FDA regulatory inspections serve as a critical measure of a CDMO's ability to meet the most stringent requirements for safety and efficacy. Supporting the client's successful BLA approval by the FDA reaffirms VGXI's continuous improvement culture and inspection readiness. The company has adopted best practices seen across leading industry peers — including proactive quality systems, rigorous documentation, unmatched expansion capacity, and real-time compliance visibility.

ABOUT VGXI, INC.
VGXI is a leader in plasmid DNA contract manufacturing, with 20+ years of experience providing high-quality products to biomedical researchers worldwide. We support clients that develop DNA vaccines, immunotherapies, cell therapies, and gene therapies. VGXI's manufacturing process and quality controls are coupled to a continuous, low-shear AIRMIX® patented lysis technology, and proprietary purification processes that provide highly supercoiled plasmid production and exceptional purity. VGXI's portfolio includes high-quality plasmid for preclinical research, Highly Documented (HD) plasmid as a critical raw material for GMP viral vector production or pharm/tox studies, cGMP plasmid DNA for clinical utilization through commercial supply, and custom services. https://www.vgxii.com.

CONTACT: Justin Smith, Director of Marketing, jcsmith@vgxii.com.

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SOURCE VGXI, Inc.