Discover answers to our most frequently asked questions, covering topics from our service offerings to our manufacturing processes, all in one convenient place.

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 1,500L 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.

Are VGXI’s plasmid manufacturing processes animal-component free?

Yes, VGXI’s uses a fully animal-free, BSE/TSE-free process.

Can VGXI manufacture plasmid DNA without using antibiotic selection?

Yes, we have optimized and validated the Nature Technology Corporation’s (NTC) HyperGRO™ fermentation system for antibiotic-free plasmid DNA production.

What concentrations of plasmid DNA can VGXI produce?

We have experience in supporting high concentration plasmid products of up to 15 mg/mL.

I have a plasmid construct but do not have a master cell bank. Do I need one to get my project started at VGXI?

That’s not a problem. Our dedicated Process Development team can evaluate a variety of cell lines to identify the optimal one for the target plasmid construct as well as identifying the best clone to generate a high-quality Master Cell Bank as part of the project scope. All our cell banking activities are performed in a dedicated area of our facilities.

Is a GMP Quality Agreement required?

Execution of a Quality Agreement is required for GMP production services and optional for HD services. Please let us know if you would like to receive the VGXI template Quality Agreement for review.

How is an audit scheduled?

The VGXI facility is available for Client or required Regulatory Agency audits. The MSA defines audit eligibility and frequency. Audits can be scheduled by the head of QA or Client Project Manager.

Why is a Plasmid Evaluation performed for new plasmids?

The Plasmid Evaluation assesses the quality and yield of the Client’s plasmid with the VGXI process. The final Plasmid Evaluation summary defines all process parameters used, observations and/or recommendations to implement for full-scale production. The summary report transfers plasmid-specific process parameters to the HD/GMP production team.

What regulatory support does VGXI offer?

For all GMP products, VGXI will supply the following: SOP 1005 Site Master File, true and correct copies of all records related to the production of GMP materials, signed original Certificates of Analysis for all released products, and other required CMC information as applicable. Additional support for regulatory questions or regulatory meetings (as applicable) can be provided subject to scheduling availability. Additional costs apply.

Is shipping included in the project proposal?

All shipping related costs for products, materials, and hard copy documents, as applicable, will be billed to the client following completion of the shipment. These fees may include shipping supplies, handling, taxes and duties.

How are product inventory updates provided?

Storage fee notices are issued quarterly in advance to communicate any changes in client inventories or associated storage fees.