VGXI


VGXI is a leading-edge CDMO dedicated to revolutionizing the biopharmaceutical industry with best-in-class nucleic acid-based products and services. They specialize in plasmid DNA manufacturing, supporting the development of next-generation therapeutics such as gene therapy, cell therapy, immunotherapy, and vaccines. With state-of-the-art facilities and over two decades of expertise, VGXI aims to provide high-quality, scalable, and regulatory-compliant plasmid DNA solutions worldwide, fostering innovation and advancing healthcare.

Industries

Health Care
Biopharma
Clinical Trials
Biotechnology
Manufacturing
Biotechnology Research

Nr. of Employees

medium (51-250)


Patents

Compositions comprising high concentration of biologically active molecules and processes for preparing the same

US-11453855-B2

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Products

HD Plasmid

A GMP-like plasmid DNA production service offering enhanced compliance options for clinical applications, utilizing the same manufacturing technology as cGMP production with faster turnaround and cost-effectiveness.

HD Plasmid DNA

Highly Documented (HD) Plasmid Production Service offering high supercoil, low endotoxin plasmid, suitable for use as an ancillary raw material in cGMP manufacturing and IND enabling studies.

Plasmid DNA Manufacturing

Pre-clinical service offering for plasmid DNA manufacturing supporting early development stages up to 100L scale.

GMP Plasmid DNA Manufacturing

GMP service offering for plasmid DNA manufacturing up to 1,500L scale.

Pre-Clinical

VGXI’s Pre-Clinical Plasmid DNA Production Service offers high purity, low endotoxin plasmid DNA specifically designed for pre-clinical development of advanced therapeutic modalities, such as gene therapies and DNA vaccines.

Pre-Clinical Plasmids

High purity and low endotoxin plasmid DNA specifically designed for pre-clinical development of advanced therapeutic modalities, including gene therapies and DNA vaccines.

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Services

High-purity plasmid preparations scaled and documented for early research and in vivo animal studies.

High-supercoil, low-endotoxin plasmid preparations provided with expanded documentation for use as ancillary raw material in GMP manufacturing and IND-enabling studies.

GMP-compliant production of injectable-grade plasmid DNA for human clinical trials, diagnostics, and as raw material for cell and gene therapy manufacturing.

End-to-end manufacturing services including process development and optimization, technology transfer support, GMP cell banking and testing, bulk and product stability testing, fill/finish, and rapid turnaround manufacturing; reported capability to support RNA production.

Expertise Areas

  • Plasmid manufacturing and scale-up
  • Analytical testing and QC for plasmid DNA
  • cGMP manufacturing and regulatory compliance for clinical supply
  • Process development and technology transfer
  • Show More (4)

Key Technologies

  • E. coli fermentation (batch and fed-batch) up to 1500 L
  • Low-shear continuous cell lysis
  • Downstream chromatography for impurity removal
  • Tangential flow ultrafiltration / diafiltration (UF/DF)
  • Show More (7)

News & Updates

The Cell & Gene Meeting on the Mesa is the foremost annual gathering for senior executives in the cell and gene therapy industry, featuring discussions on clinical trial design, payment models, and supply chain platforms.

An overview of DNA vaccines, their development, applications, and future prospects, including the recent approval of ZyCoV-D for COVID-19.


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