VGXI, lnc.
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
Nr. of Employees
medium (51-250)
VGXI, lnc.
The Woodlands, Texas, United States, North America
Products
cGMP Plasmid Production Service
Produces injectable-grade plasmid DNA for human clinical trials, diagnostic reagents, and GMP production of cell and gene therapies.
HD Plasmid Production Service
Provides high supercoil, low endotoxin plasmids for use as ancillary raw material in cGMP manufacturing and IND enabling studies.
Pre-clinical Plasmid Production Service
Delivers high purity plasmid preparations for early research, in vivo animal studies, and preclinical assessments for advanced therapies.
Manufacturing Services
Offers process development and optimization, tech transfer support, GMP cell banking and testing, bulk stability testing, fill/finish services, product stability testing, rapid TAT manufacturing, and RNA production.
Gene Therapy
Involves the introduction or modification of genetic material into a patient’s cells to correct or replace faulty genes, aiming to treat or cure genetic diseases.
Cell Therapy
Involves the genetic modification of cells outside the body before infusion into the patient to combat diseases, such as CAR T-cell therapy for treating certain cancers.
cGMP Plasmid Production Service
Produces injectable-grade plasmid DNA for human clinical trials, diagnostic reagents, and GMP production of cell and gene therapies.
HD Plasmid Production Service
Provides high supercoil, low endotoxin plasmids for use as ancillary raw material in cGMP manufacturing and IND enabling studies.
Pre-clinical Plasmid Production Service
Delivers high purity plasmid preparations for early research, in vivo animal studies, and preclinical assessments for advanced therapies.
Manufacturing Services
Offers process development and optimization, tech transfer support, GMP cell banking and testing, bulk stability testing, fill/finish services, product stability testing, rapid TAT manufacturing, and RNA production.
Gene Therapy
Involves the introduction or modification of genetic material into a patient’s cells to correct or replace faulty genes, aiming to treat or cure genetic diseases.
Cell Therapy
Involves the genetic modification of cells outside the body before infusion into the patient to combat diseases, such as CAR T-cell therapy for treating certain cancers.
Services
Pre-clinical plasmid production
High-purity plasmid preparations scaled and documented for early research and in vivo animal studies.
Highly documented plasmid raw material for GMP/IND enabling
High-supercoil, low-endotoxin plasmid preparations provided with expanded documentation for use as ancillary raw material in GMP manufacturing and IND-enabling studies.
cGMP plasmid manufacturing for clinical supply
GMP-compliant production of injectable-grade plasmid DNA for human clinical trials, diagnostics, and as raw material for cell and gene therapy manufacturing.
Manufacturing services: process development, tech transfer, and support
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.
Pre-clinical plasmid production
High-purity plasmid preparations scaled and documented for early research and in vivo animal studies.
Highly documented plasmid raw material for GMP/IND enabling
High-supercoil, low-endotoxin plasmid preparations provided with expanded documentation for use as ancillary raw material in GMP manufacturing and IND-enabling studies.
cGMP plasmid manufacturing for clinical supply
GMP-compliant production of injectable-grade plasmid DNA for human clinical trials, diagnostics, and as raw material for cell and gene therapy manufacturing.
Manufacturing services: process development, tech transfer, and support
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
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)