BioMARC manufacturing vaccines for Department of Defense
Colorado State University is aiding in the development of vaccines to protect U.S. soldiers from Ebola and Marburg, both deadly diseases caused by filoviruses.
BioMARC, a high-containment biopharmaceutical facility operated by CSU, is manufacturing the vaccines for the U.S. Department of Defense in support of human clinical trials.
The CSU center received the $2 million subcontract through the DOD’s Medical Countermeasures Systems Joint Vaccine Acquisition program, which develops, procures and stockpiles vaccines to protect soldiers from biological warfare agents.
“Colorado State has long been on the front lines of fighting infectious diseases in humans and animals – from retroviruses to vector-borne viral diseases,” President Tony Frank said. “We’re proud now to be able to put our resources and expertise to work in the pressing fight against Ebola.”
Since Ebola was detected in late 2013 in Guinea, the deadly virus has spread into other West African countries, Europe and even the United States.
As of Oct. 22, the Centers for Disease Control and Prevention reported more than 4,800 people have died from Ebola– making it the worst outbreak since the virus was discovered in the 1970s.
“BioMarc is well positioned to contribute advanced manufacturing assets to important global problems such as Ebola,” said CSU’s Vice President for Research Alan Rudolph. “It is a unique asset for CSU, and we are excited to help the Defense Department execute this important vaccine development program.”
Using non-infectious particles
BioMARC will begin manufacturing the vaccines by the end of the year, using a technique called Viral Replicon Particles, which does not use live or infectious viruses.
“This is a fairly new technique that requires cutting-edge equipment, which CSU has invested in at BioMARC,” said Dennis Pierro, a CSU professor and director of BioMARC. “One of the reasons we were awarded this contract is because BioMARC has the unique infrastructure to handle this kind of VRP technology.”
With conventional vaccine techniques, live viruses are grown in a laboratory so antigens can be extracted. (Antigens are the part of a virus or bacteria that causes the immune system to attack the virus and produce antibodies to prevent infection.) Other substances are then added to bolster the body’s immune response to the antigen and extend the vaccine’s shelf life.
The VRP technique eliminates the need for a live virus. Instead, a small particle called a replicon (a genetically engineered protein production system) is matched with a non-infectious single antigen from the target virus.
This non-infectious particle is then used to replicate antigens and serves as the basis for the vaccine. Like conventional vaccines, substances are then added to increase shelf life and enhance the immunological response.
To date, there are no licensed or U.S. Food and Drug Administration-approved human vaccines or therapeutics to protect against or treat infections caused by Ebola and other filoviruses. Diseases caused by these viruses have high mortality rates; as many as 90 percent of those infected may die.
While BioMARC is developing the Ebola vaccine for soldiers, it could potentially be used to protect others.
“The military wants to protect its soldiers but it is possible that such a vaccine could be used for endemic outbreaks of filovirus infection,” Pierro said.
Q&A with BioMARC director
Dennis Pierro, a CSU professor and the director of BioMARC, answers some questions:
What is BioMARC?
BioMARC is a high containment biopharmaceutical manufacturing facility launched by Colorado State University in 2006 to help develop vaccines, diagnostics and other biologics for human health. We contract with private companies and public agencies to develop and manufacture a variety of vaccines and biological products.
Why was BioMARC selected for this project?
There are other biologic manufacturing facilities in the United States, but we are unique in that we have the higher containment infrastructure needed for this type of product. BioMARC stands apart from the few other high containment manufacturers because it has been inspected by the U.S. Food and Drug Administration as a Biosafety Level 3 clean room production facility and also by the Centers for Disease Control and Prevention.
Not many facilities can say they have both. In addition, we have a highly qualified staff who are experts in Manufacturing, Quality Assurance, Quality Control, Facilities, Project Management among others. I think our successful track record with other products in the past helped as well.
What is BioMARC’s role in the project?
We are manufacturing vaccines for the Marburg and Ebola viruses, two well-known filoviruses, in support of human clinical trials. Our facility must meet the production yield and quality requirements of the product specification, but also be compliant to Good Manufacturing Practices, which is a regulatory standard enforced by the FDA. We will be looking at ways to not only better manufacture the vaccines but opportunities to support the clinical pathway through delivering a high quality and stable drug.
So the vaccines aren’t available for use?
No. It takes 10-15 years for a vaccine to be approved for use by the FDA. Moreover, researchers spend years developing vaccines in labs before they are ready to be tested with humans. Vaccines undergo at least three phases of human clinical trials before they are submitted to the FDA for approval.
We will be manufacturing the vaccine to support this approval process. While the primary purpose of the Ebola vaccine under this contract would be to protect U.S. soldiers, it is possible that such a vaccine could be used for endemic outbreaks of filovirus infection.
Does this mean the Ebola virus is at BioMARC?
No, the virus is not at our facility. We are using one protein from the virus to make the vaccine. We do not use the Ebola virus to make the vaccine. No one is danger of contracting Ebola from our work. We take this very seriously and safety is our top priority.
BioMARC is certified by the U.S. Food and Drug Administration as a Biosafety Level 3 Laboratory.
BioMARC is manufacturing Ebola and Marburg vaccines in support of human clinical trials.
BioMARC will not use live viruses to manufacture the vaccines.
Dennis Pierro is a CSU professor and director of BioMARC.
BioMARC will start manufacturing the vaccines by the end of the year.
Infographic: Snapshot of Vaccine Development