COLLEGE PARK, Md., Feb. 8 /PRNewswire/ -- BioFactura Inc. is developing a therapy for smallpox using the University of Maryland’s Bioprocess Scale-Up Facility.
The Rockville-based company is collaborating with Fort Detrick, a U.S. Army Medical Command Installation in Frederick, Md., in hopes of commercializing a product within four years. BioFactura will use the Bioprocess Scale-Up Facility to find the best way to manufacture the drug at a large scale.
“The Scale-Up Facility has state-of-the-art equipment,” said BioFactura’s Chief Science Officer Darryl Sampey. “The value for price is unsurpassed, which is critically important for a small company with limited funds.”
Smallpox, characterized by a rash of lesions, killed an estimated 300 million people in the twentieth century alone before it was declared globally eradicated in 1980. The government has labeled the disease a “Category A” agent -- presenting the “greatest potential threat for harming public health,” according to the Centers for Disease Control and Prevention.
The virus, transmitted by contact or through the air, can survive in dust, bedding and clothing, even traveling through air ducts. “Although anthrax proved to be a deadly bioterror agent, a smallpox attack could be devastating,” said Sampey.
Since routine vaccinations for children were discontinued in 1972 and studies have shown the vaccine is less effective after five years, the American population is highly vulnerable to the virus. The threat of this agent in the hands of terrorists has caused the government to recently pour funds into developing new, safer vaccines. An effective therapy would be of even greater benefit.
BioFactura recently received a Small Business Innovation Research (SBIR) Phase 1 Grant from the Department of Defense to develop the therapy against smallpox.
The risk of human exposure to the disease renders human efficacy trials impossible, shortening the development phase of the therapy, according to Sampey. The FDA has established a regulatory pathway to drug approval that includes animal studies to show efficacy and a Phase I human clinical trial to demonstrate safety, he explained.
With help from the university’s Bioprocess Scale-Up Facility a cure for this historically lethal disease may be in sight. “It would be one of the only smallpox therapies known to man, and be one of the largest products to come out of our lab,” said Ben Woodard, director of the Scale-Up Facility.
About BioFactura (http://www.biofactura.com)
BioFactura Inc. is a biotechnology company developing innovative biopharmaceuticals as well as offering process development and manufacturing services to customers and partners seeking to bring promising therapeutics, vaccines, and diagnostics to commercial markets.
About the Bioprocess Scale-Up Facility (http://www.biotech.umd.edu)
The Bioprocess Scale-Up Facility, a unit of the University of Maryland’s A. James Clark School of Engineering, is a modern bioprocessing laboratory dedicated to developing and scaling up biotechnology products and processes. The BSF has conducted nearly 700 fermentations since 1998 for companies and government laboratories, including Martek Biosciences, Digene Corporation and Human Genome Sciences, and the National Institutes of Health.
Maryland Technology Enterprise Institute
CONTACT: Megan Hartley, +1-301-405-4548, mhartley@umd.edu, or Eric Schurr,+1-301-405-3889, schurr@umd.edu, both of the Maryland Technology EnterpriseInstitute
