Lincoln, NE (PRWEB) June 16, 2012
USDA issues a conditional license for first ever U.S. made FMD vaccine for cattle. License issued to Benchmark BioLabs Affiliate Company, Antelope Valley Bios, Lincoln, Nebraska.
Benchmark Biolabs Inc. announces that a conditional license was granted today by the United States Department of Agriculture (USDA) Center for Veterinary Biologics, approving production of a novel bio-engineered foot-and-mouth disease (FMD) vaccine for cattle by Benchmark’s affiliated company, Antelope Valley Bios, at its plant in Lincoln, Nebraska.
This conditional license is the result of a four-year collaboration between the Lincoln, Nebraska-based Antelope Valley Bios, with GenVec Inc., of Gaithersburg, MD, Department of Homeland Security (DHS) Science and Technology Directorate and the Plum Island Animal Disease Center (PIADC) near Greenport, New York.
FMD is a devastating disease of cattle, sheep and swine that is endemic in many countries. The United States, however, has been declared free of foot-and-mouth disease, and USDA has multiple layers of protection to continuously safeguard American livestock from the threat of contracting this economically catastrophic disease. Among the USDA preparedness programs have been provision for FMD vaccine supplies in the event these would be needed during a future FMD outbreak. Development and manufacturing of a conventional FMD vaccine inside the United States, however, had never been possible, because the handling of the FMD virus during vaccine production had been considered an unjustifiable risk to the livestock population here.
To control the risk of FMD being released into the American livestock population, federal law has long prohibited handling live FMD virus anywhere inside the United States (with the exception of PIADC, which is located on an island), even where such work would be aimed at FMD prevention and/or vaccination studies. As a result, USDA has been unable to acquire U.S.-origin FMD vaccine for use in its emergency vaccine stockpiling efforts but has had to source emergency supplies from abroad. Only a limited number of FMD vaccine types are available from non-U.S. suppliers. In order to improve vaccine acquisition, flexibility and preparedness a new technology platform was developed by collaboration of scientists from DHS S&T PIADC with the biotechnology firm, GenVec Inc. This work resulted in a unique vaccine candidate being bioengineered as a first of its kind: an avirulent adenovirus bioengineered to express certain key FMD proteins. The vaccine candidate was developed to be able to survive injection and immunize animals but to be incapable of longer-term survival outside a laboratory or production plant setting.
This vaccine candidate was the basis for a manufacturing process brought to practical application by Benchmark Biolabs at its Lincoln, Nebraska headquarters. The technology platform the collaborators arrived at allows vaccine production to be completed without ever having to handle live FMD virus. The new technology results in production of vaccine in a fully contained safe manufacturing setting at Benchmark’s Antelope Valley Bios with no risk of FMD exposure of any U.S. livestock.
Because the vaccine protects against FMD but does not contain the FMD virus itself, the FMD-protective antibody produced by vaccinated animals will be readily differentiated from the antibody produced as a result of the disease exposure itself. As a result, in an outbreak situation, cattle vaccinated with this new vaccine would readily be distinguished by simple serum tests from cattle exposed to the disease. “The availability of this vaccine to governmental authorities during management of a future FMD emergency would be a powerful new tool never before available to veterinary authorities facing FMD management responsibilities” said Timothy Miller, Ph.D. President of Benchmark Biolabs.
The bioengineered FMD vaccine was proven highly efficacious in testing by the DHS within their high-level containment Plum Island testing facilities near Greenport, New York. Field testing proved the vaccine can be safely administered to cattle under normal U.S. cattle production conditions.
“Benchmark’s contribution to this project began when our collaborators presented us with an opportunity to apply our skills in process development to their very elegant scientific solution to the FMD production problem. Our job was to partner with these innovators and help move their invention from the proof of concept stage, through process development and on into a controlled manufacturing environment, completing the requirements for the USDA’s conditional product license along the way,” Miller explained. “The importance of protection of American livestock and meat supplies against accidental or intentional outbreaks of FMD cannot be over-stated. Collaboration of this sort is what Benchmark is all about. The driving technology behind this vaccine will serve as a pathway to practical production of other vaccines that might be too hazardous to manufacturing personnel or to the environment to be tackled by more conventional means. It is gratifying to see the efforts of our company and of our collaborators rewarded with a USDA conditional licensure today. We couldn’t be more proud.”
Over its 15 years of service to the pharmaceutical and biotech industries, Benchmark has provided its clients with a full range of scalable services; focused on the validation, development, licensure, and commercialization of unique technologies. Collectively, Benchmark scientists are responsible for over 60 issued patents, dozens of USDA and FDA approved products, and many groundbreaking technology introductions.
To learn more about Benchmark Biolabs, Inc. please visit http://www.benchmarkbiolabs.com
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