Woodlands based DNA Plasmid manufacturer receives $45M grant for Ebola vaccine

THE WOODLANDS, Texas - A breakthrough in infectious disease control, specifically Ebola, is evolving, and it’s taking place right here in The Woodlands. A $45 million dollar DARPA (Defense Advanced Research Projects Agency) grant was awarded to Inovio Pharmaceuticals, Inc., that has enabled the company to produce the vaccine at the facility of its manufacturing partner, VGXI in The Woodlands, in an effort to expedite the development for prevention and treatment of Ebola.

Due to the global concerns and immediacy of need, an aggressive timeline has been set for the development of the Ebola vaccine. A Phase 1 clinical trial will begin within a couple of weeks to test the vaccine.

Congressman Kevin Brady (R) of the Texas 8th congressional district toured the manufacturing plant to view the VGXI process. In addressing the employee team, Brady emphasized the importance of their work and it’s global impact.

“Because of your dedication and passion for your work, you’re making products that can save people’s lives,” said Congressman Brady.

The 2014 Ebola epidemic was the largest in history, affecting multiple countries in West Africa. To stave off a pandemic, a sense of urgency has expedited the manufacturing of a vaccine. Vice President of Operations, Dorothy Peterson, credited Congressman Brady with making the funding for a vaccine possible.

VGXI is a full service contract manufacturing organization that manufactures DNA plasmids for human clinical trials, virus production, toxicology studies, and pre-clinical research, and has been developing vaccines for fifteen years. The company has a proven track record of producing effective high quality plasmid DNA for many viral diseases and immunotherapies, which have included vaccines for Influenza (Flu), human papillomavirus (HPV), human immunodeficiency virus (HIV), Cervical intraepithelial neoplasia (CIN)...also referred to as cervical dysplasia. Their success is the result of a patented process for producing synthetic Plasmid DNA.

“The gene of interest is inserted into a plasmid backbone,” said Manufacturing Manager, Stephen Rodriguez. “Plasmid backbones are genetically engineered as a template for easy additional genetic manipulation.”

Plasmid DNA are naturally occurring pieces of DNA found in many bacteria, the plasmid DNA VGXI manufactures has been modified for optimal product yield, safety, and efficacy. The are three main process steps in the manufacturing of plasmid DNA.

Fermentation - accomplished using E. coli production techniques growing the fermentation culture under strictly controlled parameters, to produce the bacteria and provide the materials needed for the plasmid to replicate within each cell.

Purification - Chemical breakdown of the cells (lysis) in a controlled method to release the plasmid molecules. Cell debris is then removed by filtration (no bacteria is present after this step). A second purification procedure takes place using an ion exchange to remove the majority of the unwanted E.coli impurities, and a final purification process (Hydrophobic Interaction Chromatography) further reduces impurities.

Testing - The final product is tested to meet all quality specifications and filled into vials for administration for the clinical Phase I and Phase II study sites. Inovio will oversee the collaborative team that will conduct the clinical trials.

“We manufacture and purify Inovio’s Ebola plasmid DNA using E.coli to replicate the DNA,” said Rodriguez. “E.coli bacteria is used because it grows quickly and has a proven safety record in the pharmaceutical industry.”

These therapies are different from other Ebola vaccines currently in development because the vaccine contains DNA only...no virus particles or proteins are being manufactured. The vaccine can be used to treat to patients who have already been exposed to the virus, and it can be scaled up rapidly in the event of an outbreak.

“Let me reassure you that we do not have Ebola here at our facility,” said CEO and President, Young K. Park. “We are just manufacturing the vaccine here at VGXI.”

Park reiterated that none of the products will contain any Ebola virus or viral particles. The sense of urgency is the result of the highly infectious Ebola virus because it spreads by direct contact with body fluids such as blood, from an infected human or other animals. It may also occur through contact with an item recently contaminated with bodily fluids. Fruit bats are believed to be the normal carrier in nature, and able to spread the virus without being affected by it.

This unique DNA process is not limited to infectious diseases. It’s application is being used for cancer research as well.

“We can also apply this technology to bolster the body’s immune system to attack cancer cells, using the body’s own immune system. It’s a safer and more effective way,” said President and CEO of Inovio, J. Joseph Kim, Ph.D. “We can get rid of invasive surgery and chemotherapy to fight cancer.”

VGXI’s slogan is…”Quality...it’s in our DNA.” In 2013 and 2014 VGXI won the Vaccine Industry Excellence (ViE) Award for Best Contract Manufacturing Organization.

In his closing statements Congressman Brady stated, "Quality work is the result of quality people."