VGXI

What VGXI does

VGXI is a US-based contract development and manufacturing organization (CDMO) specializing in plasmid DNA for advanced therapies, founded in 1997 in The Woodlands, Texas and operating since 2003 as a wholly-owned subsidiary of the South Korean biotech GeneOne Life Science, Inc. (KOSPI: 011000). The company manufactures plasmid DNA across three service tiers — Pre-clinical, Highly Documented (HD), and cGMP — at fermentation scales from 10L up to 1500L, using its patented AIRMIX® continuous low-shear lysis technology and optimized downstream chromatography, supported by GMP cell banking, aseptic fill/finish, and analytical QC capabilities. VGXI claims the world's largest pure-play cGMP plasmid manufacturing footprint, with 160,000+ sq ft of FDA-compliant space across a 120,000 sq ft headquarters at Deison Technology Park in Conroe and a 40,000 sq ft facility in The Woodlands, plus reserved land for an additional 500,000+ sq ft of expansion.

VGXI serves gene therapy developers (AAV and lentiviral vector programs), cell therapy companies (CAR-T and ex vivo gene-modified therapies), DNA vaccine and immunotherapy developers, mRNA therapeutics manufacturers (via linearized plasmid templates), and government public-health agencies (BARDA-aligned pandemic preparedness work). Its commercial roster spans early-phase biotech startups, late-phase gene therapy developers, and enterprise clients including Sutro Biopharma at 1500L scale for an ADC program, plus nonprofit research partnerships such as with the Institute for Molecular Medicine on an Alzheimer's DNA vaccine. Pricing is project-based and quote-driven, structured around multi-year service contracts tiered by quality level, scale, and add-on services.

The go-to-market is direct B2B enterprise sales supplemented by event-driven demand generation at industry conferences (BIO, ARM Meeting on the Mesa, CGT Asia), and the company positions around regulatory depth (multiple FDA inspections and international approvals, three commercial phase programs since 2019) and supply chain consolidation for clients seeking US-based plasmid capacity. Revenue is not publicly disclosed; based on headcount, infrastructure footprint, and public-parent context, revenue is estimated in the $25M-$50M band with low confidence.

Name

VGXI

Legal name

VGXI, Inc.

Website

https://vgxii.com

Company type

Private

Founded year

1997

Operating status

Operating

Headcount range

101–250 employees

Short description

VGXI is a US-based contract DNA plasmid manufacturer (CDMO) serving gene therapy, cell therapy, DNA vaccine, and mRNA therapeutic developers through cGMP-compliant production at scales up to 1500L. It is a wholly-owned subsidiary of GeneOne Life Science (KOSPI: 011000) and operates the world's largest pure-play plasmid DNA facility.

Ownership category

akta.pro rank

Product category

Contract Plasmid DNA Manufacturing (CDMO)

NAICS

Research and Development in Biotechnology (except Nanobiotechnology) (541714), Pharmaceutical Preparation Manufacturing (325412), Pharmaceutical and Medicine Manufacturing (3254)

SIC

Services-Commercial Physical & Biological Research (8731), Pharmaceutical Preparations (2834)

akta.pro primary industry

Plasmid DNA & mRNA Manufacturing Services (HLAAAKAE)

akta.pro secondary industries

mRNA/LNP & Nucleic Acid Therapeutics CDMO (HLAGABAF), Gene Therapy CDMO (Viral Vector Manufacturing) (HLAGAGAB)

Keywords

• Plasmid DNA manufacturing
• Contract manufacturing services
• CGMP plasmid production
• Cell and gene therapy CDMO
• DNA vaccine manufacturing

Headquarters

HQ city

The Woodlands

HQ country

United States

HQ region

North America

Offices2 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Technology or R&D, Infrastructure, Marketing or Sales

Revenue model

1. Contract Manufacturing Services: VGXI generates revenue through contract development and manufacturing services for plasmid DNA products. Services span pre-clinical plasmids, Highly Documented (HD) plasmids, and cGMP plasmids at scales from 10L to 1500L fermentation. Revenue is project-based with pricing dependent on service level, scale, and project complexity. The company provides end-to-end solutions including process development, cell banking, fill/finish, and stability testing as part of comprehensive CDMO engagements.

Pricing tiers

Go-to-market motion2 records

Distribution channels1 record

Marketing channels4 records

Core offering

VGXI is a Contract Development and Manufacturing Organization (CDMO) that manufactures plasmid DNA under cGMP for use in human clinical trials, gene therapies, cell therapies, DNA vaccines, and mRNA therapeutics. The company operates across three quality tiers — Pre-clinical Plasmid DNA, Highly Documented (HD) Plasmid DNA, and cGMP Plasmid DNA — at fermentation scales from 10L to 1500L, complemented by linearized plasmid DNA services and end-to-end manufacturing capabilities including process development, GMP cell banking, fill/finish, and analytical testing.

Product overview

VGXI is a Contract Development and Manufacturing Organization (CDMO) specializing in plasmid DNA manufacturing with over 20 years of experience. The company offers a comprehensive portfolio of plasmid DNA products and services across three quality tiers: Pre-clinical Plasmid DNA for early research and preclinical studies, HD (Highly Documented) Plasmid DNA as a GMP-like alternative for IND-enabling studies and raw material supply, and cGMP Plasmid DNA for injectable-grade clinical and commercial production. Supporting these core products are Linear Plasmid DNA services for mRNA therapeutics, and comprehensive Manufacturing Services including process development, cell banking, fill/finish, and stability testing. VGXI serves three primary application areas: Gene Therapy (AAV vectors), Cell Therapy (CAR T-cell), and Immunotherapy & DNA Vaccines. The company operates 160,000 sq ft of FDA-compliant facilities in Texas and holds the largest plasmid DNA manufacturing capacity (4000L) globally. VGXI is a wholly-owned subsidiary of GeneOne Life Science Inc. (KOSPI: 011000).

Differentiator

Problem solved

Functional benefit

Products and services

• Pre-clinical Plasmid DNA High-purity, low-endotoxin plasmid DNA production service for pre-clinical development of advanced therapeutic modalities including gene therapies and DNA vaccines, supporting early research, in vivo animal studies, and preclinical safety/toxicology studies at fermentation scales of 10L–100L.
• HD (Highly Documented) Plasmid DNA Highly Documented (HD) plasmid production service providing high supercoil, low endotoxin plasmids for use as ancillary raw material in cGMP manufacturing and IND-enabling studies. GMP-like quality with up to 500L fermentation scale, up to 20g plasmid DNA delivered, suitable for plasmids up to 19kb.
• cGMP Plasmid DNA Injectable-grade cGMP plasmid DNA manufacturing service for human clinical trials, diagnostic reagents, and clinical through commercial supply of raw materials for GMP viral vector and cell therapy production, with fermentation scales up to 1500L and GMP cell banking and fill/finish options.
• Linear Plasmid DNA Linearized plasmid DNA service providing optimal templates for mRNA therapeutics development through in vitro transcription (IVT), ensuring high-quality linearized pDNA for therapeutic research and production with up to 1500L fermentation scale.
• Manufacturing Services Comprehensive end-to-end manufacturing solutions including Process Development & Optimization, Tech Transfer Support, GMP Cell Banking & Testing, Bulk Stability Testing, Fill/Finish Services, Product Stability Testing, Rapid TAT Manufacturing, and RNA Production — available as add-on services to plasmid DNA manufacturing engagements.

Quantifiable outcome

• 310+ cGMP batches and 3+ kilograms of injectable-grade plasmid DNA manufactured since 2005
• +3 more outcomes

Named customers6 records

Segments5 records

Ideal customer profiles5 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature5 records

Partnerships

Eight partnerships are on record, tiered core and minor.

• CryoportcoreTechnology or Integration · 15 October 2024Strategic partnership for biostorage and bioservices to support cell and gene therapies and mRNA-based treatments. Cryoport Systems provides biostorage and bioservices from its Houston, Texas facility for plasmid DNA products manufactured at VGXI's Texas facilities, bringing together VGXI's plasmid DNA manufacturing expertise with Cryoport's integrated supply chain solutions including shipping, data solutions, and comprehensive support services.
• Biopharmaceutical Manufacturing Preparedness (BioMap) ConsortiumcoreStrategic or Co-development Partner · 20 August 2024VGXI accepted as member of the BioMap Consortium, which focuses on expanding US biopharmaceutical industrial capabilities and bio-manufacturing output. Supported by BARDA's Pharmaceutical Countermeasure Infrastructure Division and BioMap Branch, the consortium includes 200+ member firms working to ensure adequate manufacturing capabilities for rapid medical countermeasure delivery.
• Rapid Response Partnership Vehicle (RRPV)coreStrategic or Co-development Partner · 30 July 2024VGXI selected as member of RRPV which supports BARDA in accelerating Medical Countermeasure product and technology development to address pandemic influenza, emerging infectious diseases, and other biological threats. VGXI brings experience in manufacturing vaccines for Ebola, MERS, COVID-19, and other infectious diseases.
• Sutro Biopharma Inc.coreStrategic or Co-development Partner · 3 June 2024Strategic partnership to support clinical production of luveltamab tazevibulin (luvelta), a Folate Receptor-α targeting antibody-drug conjugate (ADC). VGXI supplies cGMP plasmids at 1500L production scale for use in Sutro's XpressCF® cell-free expression system to manufacture luvelta for the REFRαME-O1 registration-directed clinical trial in platinum-resistant ovarian cancer.
• Rare Trait Hope FundminorStrategic or Co-development Partner · 10 August 2021Partnership to support manufacturing of plasmid DNA raw material for AAV-based gene therapy for Aspartylglucosaminuria (AGU), a rare lysosomal storage disorder. VGXI leverages optimized DNA production process to supply critical materials for the therapy developed by researchers at University of North Carolina and UTSW Dallas. VGXI contributed a portion of manufacturing costs recognizing family fundraising efforts.
• GeneOne Life Science Inc.coreOthersVGXI is a wholly-owned subsidiary of GeneOne Life Science Inc. (KOSPI: 011000), an international biotechnology company headquartered in Seoul, South Korea. GeneOne researches and develops DNA vaccines and products to prevent and treat incurable diseases, with recent expansion into mRNA manufacturing.
• Institute for Molecular Medicine (IMM)coreStrategic or Co-development PartnerExclusive cGMP plasmid manufacturing partner for AV-1959D, a DNA vaccine aimed at Alzheimer's Disease prevention. VGXI manufactures Phase 1 clinical supply of the vaccine. IMM also received a $12M NIH grant to support the clinical trial.
• Texas A&M UniversityminorImplementation/ SI/ Consulting PartnerStrategic collaboration for workforce development and training. VGXI contributes industry insights and expertise to help shape biomanufacturing-focused curriculum content, bridging the gap between academia and industry demands while supporting the development of the next generation of scientists.

Scale indicators7 records

Recent moves8 records

Expansion highlights6 records

Broad incumbents

• Fujifilm Diosynth Biotechnologies: Fujifilm Diosynth is a major CDMO with expanding cell and gene therapy capacity, including plasmid DNA and viral vector services. Its global footprint and large-scale facilities make it a competitor for advanced therapy manufacturing contracts.
• Lonza: Lonza is a global CDMO leader with significant cell and gene therapy capability, including plasmid DNA and viral vector manufacturing. Its scale and broad biopharma services make it a relevant competitor for large biotech and pharma clients that VGXI also serves.
• Thermo Fisher Scientific (Patheon CDMO / Brammer Bio): Thermo Fisher's pharma services segment includes viral vector and plasmid DNA CDMO capabilities via Brammer Bio. It is a broad incumbent alternative for biotechs seeking integrated drug development and manufacturing services spanning plasmids through commercial supply.
• Catalent: Catalent (now owned by Novo Holdings) is a major global CDMO with cell and gene therapy services including plasmid DNA production and fill/finish. It competes with VGXI for gene therapy and cell therapy biotech clients but offers a much broader service portfolio.
• AGC Biologics: AGC Biologics is a global CDMO providing cell and gene therapy services including plasmid DNA production. Its diversified biologics and gene therapy manufacturing offering competes with VGXI for advanced therapy biotech clients seeking integrated CDMO solutions.
• Charles River Laboratories: Charles River provides CDMO and contract development services for biologics, including plasmid DNA and viral vector manufacturing. Its broad biopharma services portfolio and established global footprint make it a competing choice for biotechs seeking plasmid supply alongside broader preclinical and clinical services.

Emerging players

• Resilience: Resilience is a U.S.-focused biomanufacturing CDMO investing in cell and gene therapy production, including nucleic acid manufacturing. Its mission to onshore critical biopharma manufacturing aligns with VGXI's U.S. capacity positioning for BARDA/eligible clients.

Others

• National Resilience / Department of Defense Biomanufacturing Consortiums: Federal biomanufacturing consortiums (e.g., BioMap, RRPV) are ecosystem participants that shape domestic plasmid DNA capacity allocation and funding. While not a commercial peer, these entities directly compete for the same medical countermeasure wallet share VGXI targets.

Direct peers

• GenScript ProBio: GenScript ProBio is a global CDMO offering plasmid DNA, viral vector, and cell therapy manufacturing services. It is a direct competitor in plasmid DNA CDMO for gene therapy and vaccine developers, with particularly strong reach into APAC markets.
• Aldevron: Aldevron (now part of Danaher) is a leading plasmid DNA, mRNA, and protein CDMO serving gene therapy and vaccine developers. It is the most direct pure-play comparable to VGXI given overlapping plasmid DNA, GMP manufacturing focus, and biotech customer base.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/vgxi

Compliance2 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles6 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about VGXI