VGXI

VGXI

GMP DNA plasmid contract manufacturer

Overview

VGXI is a contract manufacturing organization that produces DNA plasmids under GMP for human clinical trials. The company uses a specialized AIRMIX lysis technology to create high-purity, highly concentrated plasmid formulations ranging from 1 to 15 mg/mL, enabling low-volume and multi-plasmid preparations. With about two decades of experience, VGXI has manufactured over 175 batches of clinical-grade DNA for trials across the U.S., Canada, Europe, Asia, and Australia, supported by a team of process development scientists and a purpose-built GMP production facility. This combination helps ensure the success of challenging clinical programs. VGXI differentiates itself through its patented AIRMIX lysis method, long track record, global reach, and specialized in providing reliable plasmid supplies for clinical development. The company’s goal is to support worldwide clinical programs by delivering consistent, high-quality plasmids that meet regulatory requirements for human trials.

About VGXI

Simplify's Rating
Why VGXI is rated
D+
Rated B on Competitive Edge
Rated D+ on Growth Potential
Rated D- on Differentiation

Industries

Industrial & Manufacturing

Biotechnology

Healthcare

Company Size

51-200

Company Stage

N/A

Total Funding

N/A

Headquarters

The Woodlands, Texas

Founded

1997

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Simplify's Take

What believers are saying

  • May 2025 FDA success supported a client's BLA approval milestone.
  • Resilience and Sutro partnerships keep VGXI embedded in active advanced-therapy supply chains.
  • Management says 2026 restarts and new projects will reopen plants and restore revenue.

What critics are saying

  • VGXI halted operations October 16, 2025 after GeneOne funding delays.
  • Montgomery County declared default in November 2025; VGXI owes $248,000 taxes.
  • The 2026 revenue zeroing and staffing cuts threaten insolvency unless financing closes fast.

What makes VGXI unique

  • VGXI passed an FDA inspection in May 2025, validating GMP plasmid quality.
  • Its 1500L plasmid scale and AIRMIX lysis technology fit complex clinical programs.
  • Sutro and Resilience partnered with VGXI in 2024 for critical plasmid supply.

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Company News

PR Newswire
Jun 3rd, 2024
Vgxi Inc. Announces A Strategic Partnership With Sutro Biopharma Inc. To Support Growing Clinical Pipeline

CONROE, Texas, June 3, 2024 /PRNewswire/ -- VGXI, Inc., a leading contract developer and manufacturer (CDMO) specializing in nucleic acid biopharmaceuticals, including gene therapies, DNA vaccines, and RNA medicines, has entered into a strategic partnership with Sutro Biopharma, Inc. (Sutro) to support clinical production of luveltamab tazevibulin, abbreviated as "luvelta", a novel Folate Receptor-α (FRα)-targeting antibody-drug conjugate (ADC) with the potential to address the unmet need in several FRα-expressing cancers.Sutro, a clinical-stage oncology company pioneering site-specific and novel-format ADCs, has just initiated the randomized portion (Part 2) of REFRαME-O1, a global, registration-directed clinical trial of luvelta (NCT05870748) in platinum-resistant ovarian cancer (PROC). VGXI will supply cGMP plasmids at 1500L production scale for use in Sutro's XpressCF® cell-free expression system to manufacture luvelta. With evidence of clinical activity and the potential to benefit 8 out of 10 PROC patients, luvelta could address a high unmet medical need in patients with low to medium FRα expression."We are thrilled to establish this partnership to support the clinical production of luvelta and all of Sutro's ongoing projects," stated Young Park, CEO of VGXI. "Our expertise in large-scale cGMP plasmid production will be instrumental in advancing Sutro's promising therapy through its late-stage clinical trial evaluation and towards commercialization.""Our partnership with VGXI has been a cornerstone in our achievements to further enable our Cell Free manufacturing platform at commercial scale as our lead product candidate progresses to registrational clinical studies," commented Dr. Venkatesh Srinivasan, Chief Technical Operations Officer, Sutro Biopharma.As the demand for advanced therapies and targeted cancer treatments continues to grow, VGXI's state-of-the-art facilities and cutting-edge technologies enable the production of high-quality cGMP plasmid materials with the scale and speed necessary to bring these treatments to patients, now and into the future.ABOUT VGXI, INC.With over 20 years of experience VGXI, Inc

PR Newswire
Mar 27th, 2024
Stephanie Burke Named As Vgxi'S New Chief Accounting Officer

CONROE, Texas, March 27, 2024 /PRNewswire/ -- VGXI, Inc., a leading contract developer and manufacturer (CDMO) specializing in nucleic acid biopharmaceuticals, including gene therapies, DNA vaccines, and RNA medicines, is pleased to announce the appointment of Stephanie Burke as the Chief Accounting Officer (CAO) for VGXI. Ms. Burke joined the company in 2015 bringing with her over a decade of accounting and leadership expertise and has since played an instrumental role in the company's financial operations.Ms. Burke has previously held leadership roles overseeing both the VGXI Accounting/Finance and Materials teams. Her expertise was essential to guide VGXI through the successful implementation of MISys, the company's electronic MRP system, to streamline manufacturing operations and enhance efficiency."I am honored to take on the position of Chief Accounting Officer," said Ms. Burke

PR Newswire
Mar 4th, 2024
Vgxi Welcomes Michael Stewart As New Chief Operating Officer

CONROE, Texas, March 4, 2024 /PRNewswire/ -- VGXI, Inc., a leading contract developer and manufacturer (CDMO) specializing in nucleic acid biopharmaceuticals, including gene therapies, DNA vaccines, and RNA medicines, proudly announces the appointment of Michael Stewart as its new Chief Operating Officer (COO). Stewart brings over 20 years of extensive experience in the viral vector therapy and vaccine production industry, which will be instrumental to VGXI's continued growth and success.Prior to joining VGXI's leadership team, Stewart served as COO at Matica Biotechnology, Inc., a CDMO providing manufacturing services for cell and gene therapy products, where he led technical functions including GMP manufacturing, supply chain, facilities and engineering, automation engineering, external project management, process engineering, process development, and assay development. He also previously held leadership roles at leading research and manufacturing organizations including Fujifilm Diosynth Biotechnologies, Boehringer-Ingelheim Biomanufacturing, Meridian Life Science, and St. Jude's Children's Research Hospital."We are thrilled to welcome Michael Stewart to VGXI as our new Chief Operating Officer," said VGXI's CEO, Young Park. "His wealth of CDMO experience and proven track record will be pivotal in our commitment to providing top-tier DNA plasmid manufacturing services to the global biopharmaceutical community. We look forward to the positive impact he will have on our business and our clients

PR Newswire
Jan 24th, 2024
Vgxi Announces Strategic Multi-Year Partnership With Resilience To Accelerate Biomanufacturing Of Advanced Medicines

CONROE, Texas, Jan. 24, 2024 /PRNewswire/ -- VGXI, Inc., a leading contract developer and manufacturer (CDMO) specializing in nucleic acid biopharmaceuticals, including gene therapies, DNA vaccines, and RNA medicines and National Resilience, Inc. (Resilience), a technology-focused biomanufacturing company dedicated to broadening access to complex medicines, have entered a strategic multi-year partnership.Under this new partnership, VGXI will serve as a trusted plasmid DNA manufacturer to support Resilience's advanced therapy manufacturing programs. VGXI's ability to achieve rapid production cycles and short delivery times for a full spectrum of clinical and commercial products is expected to significantly enhance Resilience's efficiency and overall capacity to meet the growing demand in the Cell and Gene Therapy (CGT) sector. As part of the partnership, Resilience will also gain access to VGXI's state-of-the-art suite of analytics for cell banking, drug substance and drug product.The multi-year partnership establishes an accelerated and quality-focused network to further Resilience's mission of helping researchers make their novel therapies quickly, safely and at scale. Together, VGXI and Resilience are excited to team together to enhance their vital role in expanding patient access to transformative medicines.Young Park, CEO of VGXI, expressed enthusiasm about the partnership, stating, "We are excited to collaborate with Resilience, a sterling CDMO in the cell and gene therapy space

PR Newswire
May 31st, 2023
Vgxi, Inc. Names Jeff Whitmore As New Chief Commercial Officer

VGXI has long been recognized for its exceptional quality in DNA products and services, and under Mr. Whitmore's leadership, the company aims to fuel rapid growth, consolidate its global brand positioning, and expand its client base. .

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