Frequently Asked Questions

Want to know more about any of Vigene’s products or services? Start by checking out our Research-grade and GMP FAQs. If you still have any questions, please don’t hesitate to contact us!

Research-grade FAQs

Which virus will work best for my experiments?

Below is a quick comparison of the three most popular recombinant viruses being used for research and gene therapy applications.


For more information, please read our Viral Delivery Guide or visit the AAV, Adenovirus, or Lentivirus Packaging pages.

How do I know which scale of viral packaging to select?

The scale you choose will depend on the total amount of virus you need and your application. Our small-scale packaging services are a cost-effective choice for doing pilot studies in vitro, but is not suitable for in vivo work as the viral particles are not purified. Our large-scale packaging services are ideal for in vitro or in vivo work and provide enough viral particles for most small animal studies. We also offer preclinical packaging services if you require large quantities of virus for larger animal studies (e.g. primates). We also offer clinical-grade GMP viral production for use in clinical trials or commercial manufacturing.

What are the biosafety requirements for using AAV, adenovirus, and lentivirus?

Below are our biosafety recommendations for the handling of our viruses. Please refer to your institution’s Occupational Safety and Health Office for more guidance.

Do you sell wild-type viruses?
Vigene offers only recombinant AAV, adenovirus, and lentivirus products and services. We do not work with or sell wild-type viruses.
How should viruses be stored?
For AAV and adenovirus:
Avoid repeated freeze-thaw cycles that can decrease the viral titer. Aliquot the viral stock upon arrival and keep the aliquots at -80°C for long-term storage.

 

For lentivirus:
Freeze-thaw cycles decrease lentivirus titer dramatically. Store the viral stock immediately upon arrival. Aliquot to desired vials right before use.
How does ordering and shipping work?
Please see our How to Order page for more information.

GMP FAQs

How does a GMP project differ from a research project?
GMP projects differ from research grade projects by the scale, production conditions, project complexity, and level of documentation. First, GMP projects (e.g., viral vectors for gene therapy) are conducted at a much larger scale than those typical for research because GMP projects must generate drug substance and drug product in sufficient quantities to enable clinical studies that may involve dozens or even hundreds of patients. Second and GMP projects must be under full quality assurance oversight, in validated clean rooms with controlled air supplies. Finally and GMP productions require good documentation practice and testing to ensure traceability of every step as well as safety of the drug substance and drug product. Detailed records are kept of all source materials, equipment used, responsible personnel, and testing results.
What are the biggest contributors to the cost and timescale of a GMP campaign?
GMP viral vectors are produced in dedicated manufacturing suites at scales sufficient for clinical studies. Therefore, the availability of the GMP suite can be a significant contributor to the time scale, as these facilities are often reserved months in advance. The GMP campaign requires more stringent material quality control measures in order to deliver drug products that are safe for use. As each GMP campaign is unique, all stages are customized to ensure the maximum production of viral titers in a safe, reproducible manner. The development of the unique methods required to scale up a project (process development) contributes additional time and cost.
What are the commonly overlooked components of a GMP project?
The time necessary for completion of a GMP campaign must be considered when planning a clinical study. Before viral production begins, sufficient amounts of source material (either plasmids or viral seed stocks) must be generated, and both master cell banks and working cell banks must be established for the producer cell line. In addition, many parameters involved in the scale up of the project must be optimized to ensure efficient, reliable, and robust production of material. This systematic optimization procedure, known as process development, is a critical phase of the campaign. Finally, FDA regulations require material qualification, assay development, assay qualification, release testing, and, long-term stability to ensure safety and sterility of the drug product.
What is the typical process for getting a quote?

Because every GMP campaign is unique, all quotes are individualized for the specific needs of the project. We will start with a conference call once a Non-Disclosure Agreement is in place. During the call, we will inquire about the basic project details that we will need in order to generate an accurate quote, including the following:

  • The number and types of specific vectors needed, plus the transgene sizes for each
  • The scale of the project (total virus yield)
  • What technology (materials or processes), if any, is available to be transferred to Vigene
  • Whether previous batches have been produced, and if those records are available for review
  • Whether the formulation requirements are known
  • The time frame by which the clinical-grade material must be produced
  • The country (or countries) in which the clinical trials will be held