White Papers
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Stability of Plasmid DNA - A Review of the Data
A review of stability data for plasmid pharmaceuticals accross typical storage temperatures and handling conditions.
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Comparison of VGXI’s HD and GMP Services
Side by side comparison of the differences between VGXI’s Highly Documented (HD) grade and full cGMP grade service levels for plasmid production.
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Purity by A260/280
In-depth review of the standard test method and inherent limitations for evaluating nucleic acid purity.
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Determining Plasmid Quantity for your Clinical Trial
Case studies are presented to illustrate how much plasmid is required at each stage of manufacturing – from bulk production through fill/finish and product stability studies.
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5 Qualities to Look for in a CMO
A review of five key qualities to look for when choosing a CMO to manufacture plasmid DNA for a clinical trial.
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Plasmid DNA Manufacturing Timeline
An overview of the typical steps and time required for completion of a GMP plasmid manufacturing campaign.
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Kanamycin Concentration Reduction During the VGXI Process
This white paper reviews how a common plasmid selection agent, Kanamycin, is removed during the VGXI purification process to levels that are undetectable by standard assay methods.
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Single-Use Process Equipment
White paper reviewing process and quality improvements possible through the use of single-use systems in biopharmaceutical manufacturing.
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VGXI Pre-Clinical Production Service
VGXI’s Pre-Clinical Production Service uses the same patented manufacturing technology as our GMP production.
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VGXI HD Plasmid Production Service
VGXI’s HD Production Service produces plasmids suitable for use as a raw material in cGMP viral vector manufacturing and toxicology studies.
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VGXI cGMP Production Service
VGXI's cGMP Production Service provides injectable-grade plasmid DNA suitable for human clinical trials and commercial supply.
Posters & Presentations
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ASGCT 2017 Poster Presentation
Novel Method for RNA Quantification and Exclusion from Plasmid DNA Vector Purification Process Stream
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ASGCT 2016 Poster Presentation
Challenges of Production of Nanoplasmid™ with Large Gene Insert Using the HyperGRO™ Fermentation Process
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ASGCT 2015 Poster Presentation
High Quality Plasmid DNA Manufacturing for Ex-Vivo Protein Synthesis and Viral Vector Production for Gene Therapy
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ASGCT 2014 Poster Presentation
Large Scale Production of DNA Plasmids with Complex Gene Inserts
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