Today we’d like to introduce you to Dorothy Peterson.
So, before we jump into specific questions about the business, why don’t you give us some details about you and your story.
VGXI was formed in 1997 as a Baylor College of Medicine Technology start-up developing cutting-edge technologies for the design, production, and delivery of plasmid-based therapies. At that time, the company had an animal health product in development. In 2004, the company transitioned from drug development to offering contract manufacturing services. This transition allowed full utilization of the licensed technology and expertise around the production of DNA products.
With over 20 years of experience in quality and compliance in the medical device industry, I joined the VGXI team in 2007 as the Director of Quality and was promoted to Vice President of Operations in 2011. Over my tenure with VGXI, I have played an integral role in implementing the company’s Quality System and ensuring compliance with cGMP regulations. CGMP, current Good Manufacturing Practice, is critical for any product that will be used in humans. As our clients’ DNA vaccines and gene therapies have steadily advanced, the team at VGXI has continued to develop our expertise and capacity to support our clients’ needs.
We’re always bombarded by how great it is to pursue your passion, etc – but we’ve spoken with enough people to know that it’s not always easy. Overall, would you say things have been easy for you?
As a manufacturer of clinical grade plasmid, VGXI has persisted through multiple challenges that were faced by the field of DNA vaccines and gene therapies. The concept for gene-based medicines has been around for decades, with the first clinical trials beginning in 1990. Progress was slow, however, as researchers worked to identify optimal delivery technologies and ways to alleviate the patient’s immune response. Nearly 30 years later we have finally seen the first FDA approval for such a therapy, which was granted in August of 2017.
So, as you know, we’re impressed with VGXI – tell our readers more, for example what you’re most proud of as a company and what sets you apart from others.
VGXI is a leading contract manufacturing organization (CMO) specializing in the production of cGMP plasmid DNA for use in human clinical trials. VGXI has both the capability and experience to provide the large quantities of clinical grade plasmid that are needed for therapeutic applications. In particular, our proprietary AIRMIX® Technology allows for efficient and scalable DNA production resulting in a consistent and quality product. The products VGXI manufactures have high supercoil content and low levels of impurities.
These products are used by our clients in developing cancer immunotherapies, treatments for severe allergies, and novel vaccines. For example, VGXI has recently supplied DNA vaccines for critical emerging diseases including Zika, Ebola and MERS.
So, what’s next? Any big plans?
The gene therapy industry is gaining momentum and poised for exceptional growth in the coming years. In August 2017 the US FDA approved the first gene therapy for treatment of young leukemia patients. Less than one month later the second approval was granted for a similar lymphoma treatment. Shortly thereafter an FDA panel unanimously recommended approval for a third gene therapy to treat genetic forms of blindness. These approvals validate the real potential of these technologies and will lead to greater investment and continued development of new treatments.
As a critical CMO, VGXI has already added additional manufacturing capacity in 2016 to meet the growing industry need. We anticipate continued expansion of our services and production capabilities in the next several years as these industries mature.
- Address: 2700 Research Forest Drive, Suite 180; The Woodlands, TX 77381
- Website: www.vgxii.com
- Phone: 281-296-7300
- Email: firstname.lastname@example.org
- Facebook: https://www.facebook.com/VGXI-INC-125427077485629
- Twitter: https://twitter.com/vgxi