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UNL Today Archive

Sun, Sep 14, 2003

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Meagher
MEAGHER
UNL Partners in $11 Million Grant to Develop Botulinum Vaccine

UNL is a major partner in an $11 million grant for the fast-track development of a vaccine against botulinum neurotoxin, one of the most lethal potential bioterrorism agents. UNL is part of a research team led by DynPort Vaccine Co. which also includes the U.S. Army Medical Research Institute of Infectious Diseases and HTD Biosystems Inc. UNL's Biological Process Development Facility, directed by chemical engineering professor Michael Meagher, will receive $6.5 million of the grant for its work in developing fermentation and purification processes for the botulinum vaccines. This grant is funded by the National Institute of Allergy and Infectious Diseases.

"This is an exciting project where UNL research is helping to meet the nation's urgent need for a safe, effective vaccine against a potentially deadly bioweapon," said Prem Paul, UNL vice chancellor for research and dean of graduate studies.

Botulinum neurotoxin is generally recognized as the most deadly toxin known and has been converted for use as a weapon of bioterrorism. Under the grant, the team will develop within five years the manufacturing processes for a safe and effective vaccine that will protect against all known forms of botulinum neurotoxin. These processes will then be available for transition into pilot lot manufacture of the vaccine prior to Phase I clinical testing.

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"Developing a botulinum vaccine has been difficult and complicated because botulinum neurotoxin exists as seven different serotypes -- A, B, C, D, E, F, and G -- and each requires a separate vaccine," Meagher said. The project will fast-track manufacturing process development for a vaccine in one to two years that will provide protection against serotypes A, B, C, E and F, and within five years for a vaccine that will also include protection against botulinum neurotoxin serotypes D and G -- a heptavalent vaccine.

"UNL's Biological Process Development Facility is one of the few university facilities in the U.S. with the expertise to develop manufacturing processes for recombinant vaccine and therapeutic candidates suitable for the production of proteins for clinical trials," Meagher said.

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The grant is made through a new program of the National Institute of Allergy and Infectious Diseases, a component of the National Institutes of Health which emphasizes partnerships between universities, government and the private sector to speed development of vaccines, therapeutics, diagnostics and other products needed for biodefense. Since the fall of 2001 NIAID has greatly accelerated its biodefense research program, launching more than 30 new research and construction initiatives. It has created a comprehensive strategic plan and detailed research agenda for Category A agents of bioterrorism -- those considered to be the worst bioterror threats by the Centers for Disease Control and Prevention. Category A agents include smallpox, anthrax, plague, botulism and viral hemorrhagic fevers such as Ebola.

BIOLOGICAL PROCESS DEVELOPMENT FACILITY | NIAID | NIH | USAMRIID