Answers to some of the most common questions received by our team…
What do the VGXI letters stand for?
The letters in VGXI’s name stand for “Vaccine and Gene therapy manufacturing eXcellence in Industry."
What scales of manufacturing can VGXI support?
VGXI can support fermentation scales from 10L to 100L for Pre-Clinical and Highly Documented (HD) grade plasmid. For GMP manufacturing, VGXI can support 40L to 500L scale fermentation. Yields from these production ranges are highly dependent on the individual plasmid and will be determined during an initial, small scale Plasmid Evaluation run.
What are the differences between VGXI’s “GMP like” service and full cGMP grade plasmid manufacturing?
All of VGXI’s service levels utilize an equivalent manufacturing process so that the final plasmid product is comparable in quality. The primary difference between the Highly Documented (HD) and GMP service levels is the level of compliance and the level of documentation provided. HD Production is performed in the process development lab while GMP manufacturing occurs in the GMP production plant. Testing utilizes the same validated assays, and a QA reviewed Certificate of Analysis is provided for both services. A batch record is also provided for HD Production and the product is dispositioned by VGXI QA. Download our white paper to learn more.