VGXI, Inc.

VGXI, Inc. is a leading manufacturer of DNA plasmids. We deliver flexibility, experience, reliability and value to our clients’ challenging programs. The company’s cGMP and non-cGMP products have passed rigorous international regulatory reviews. VGXI’s patented manufacturing process and cGMP production facilities give us the ability to work with your unique requirements. The unsurpassed knowledge and ingenuity of our team can be leveraged to create a custom manufacturing solution for the benefit of your organization.

VGXI can build a solid foundation for your program with our research production service. This recent offering extends our scope in response to the overwhelming requests of our clients for high-quality, research grade materials. This rapid turnaround program ensures our clients’ pre-clinical and clinical products are produced utilizing the same efficient process, personnel, and facility. Our process provides materials you can trust to build a reliable pre-clinical dataset for your development plans.

The VGXI manufacturing staff has extensive experience in the areas of Process Development, Quality Control, Quality Assurance, and Validation of plasmid-based biopharmaceuticals. Our key personnel have the expertise and skills required to enable rapid development of products that have proven challenging to advance. Finally, VGXI has an outstanding track record of success in manufacturing plasmid products under cGMP conditions for client companies as well as supplying clinical products for studies in the US and Europe.
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Locations


United States
VGXI, Inc. Manufacturing Facility
2700 Research Forest Drive
Suite 180
The Woodlands, Texas  77381
United States, North America

GMP Experience
Since 2005, VGXI has manufactured over 150 batches (over 1,000 grams) of cGMP plasmid for use in human clinical trials.

Contacts


Christy Franco, PhD
Business Development Manager

Production Lines

VGXI, Inc. Manufacturing Facility   cGMP Plasmid Production
Location: The Woodlands, Texas, United States
Main Details
Specialization:  Drug Substance (API)Drug Substance (API)
Platform:  MicrobialMicrobial
BioReactor Process:  BatchBatch
BioReactor Process:  Fed-BatchFed-Batch
BioReactor Scale:  100L-2000L500L Bioreactor
GMP Level:  Phase IIIPhase III
Biosafety Level:  Biosafety Level 1Biosafety Level 1
Single Use:  NoneNone
Additional Services
Analytical Services are AvailableAnalytical Services
Cell Banking is AvailableCell Banking
Cell Line Development is AvailableCell Line Development
Preclinical Manufacturing is AvailablePreclinical Manufacturing
Process Development is AvailableProcess Development
Viral Manufacturing is Not AvailableViral Manufacturing
Availability: Available

Last Update: 23MAR18

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VGXI, Inc. Manufacturing Facility   Highly Documented (HD) Plasmid Production
Location: The Woodlands, Texas, United States
Main Details
Specialization:  Drug Substance (API)Drug Substance (API)
Platform:  MicrobialMicrobial
BioReactor Process:  BatchBatch
BioReactor Process:  Fed-BatchFed-Batch
BioReactor Scale:  1L-100L100L Bioreactor
GMP Level:  Phase I/IIPhase I/II
Biosafety Level:  Biosafety Level 1Biosafety Level 1
Single Use:  NoneNone
Additional Services
Analytical Services are AvailableAnalytical Services
Cell Banking is AvailableCell Banking
Cell Line Development is AvailableCell Line Development
Preclinical Manufacturing is AvailablePreclinical Manufacturing
Process Development is AvailableProcess Development
Viral Manufacturing is Not AvailableViral Manufacturing
Availability: Available

Last Update: 23MAR18

Send Inquiry about this Production Line
VGXI, Inc. Manufacturing Facility   Pre-Clinical Plasmid Production
Location: The Woodlands, Texas, United States
Main Details
Specialization:  Drug Substance (API)Drug Substance (API)
Platform:  MicrobialMicrobial
BioReactor Process:  BatchBatch
BioReactor Process:  Fed-BatchFed-Batch
BioReactor Scale:  1L-100L10L Bioreactor
GMP Level:  Phase I/IIPhase I/II
Biosafety Level:  Biosafety Level 1Biosafety Level 1
Single Use:  NoneNone
Additional Services
Analytical Services are AvailableAnalytical Services
Cell Banking is AvailableCell Banking
Cell Line Development is AvailableCell Line Development
Preclinical Manufacturing is AvailablePreclinical Manufacturing
Process Development is AvailableProcess Development
Viral Manufacturing is Not AvailableViral Manufacturing
Availability: Available

Last Update: 23MAR18

Send Inquiry about this Production Line
VGXI, Inc. Manufacturing Facility   cGMP Fill/Finish
Location: The Woodlands, Texas, United States
Main Details
Specialization:  Drug Product (Fill/Finish)Drug Product (Fill/Finish)
Dosage Form:  LiquidLiquid
Batch Size:  1-5,0001-5,000
Supported Vial Size:  2 ml2 ml
Supported Vial Size:  3 ml3 ml
Supported Vial Size:  5 ml5 ml
Supported Vial Size:  10 ml10 ml
GMP Level:  Phase IIIPhase III
Biosafety Level:  Biosafety Level 1Biosafety Level 1
Additional Services
Analytical Services are AvailableAnalytical Services
Formulation Development is Not AvailableFormulation Development
Preclinical Manufacturing is AvailablePreclinical Manufacturing
Stability Studies are AvailableStability Studies
Prefilled Syringes are Not AvailablePrefilled Syringes
Viral Manufacturing is Not AvailableViral Manufacturing
Availability: Available

Last Update: 23MAR18

Send Inquiry about this Production Line

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