This will be the third round of funding from DARPA and follows on CMB’s successful optimization and feasibility studies completed in 2008 and a new, state-of-the-art cGMP pilot manufacturing facility completed at the end of 2009. This current funding will allow CMB’s H1N1 vaccine candidate to progress to Phase 1 clinical trials, therefore validating the utility of the technology for manufacturing products for use in humans.
According to Dr. Vidadi Yusibov, Executive Director of Fraunhofer USA CMB, “Over the past eight years, we have taken our plant-based transient expression system for recombinant protein production from concept, through technical innovations, process improvement, and scale up. While the production platform has been validated by extensive pre-clinical studies, we are looking forward to entering the clinical phase of development.”
The need for alternative manufacturing platforms with rapid response capability became apparent in the past year with the emergence of the H1N1 influenza. DARPA’s interest in developing advanced manufacturing technologies for vaccine production stems from the need to protect military personnel and civilian populations from infections agents.
When asked their opinions on this latest announcement from Fraunhofer CMB, members of Delaware’s Congressional delegation made the following comments.
"Fraunhofer’s work to help fight the spread of the H1N1 influenza virus is on the cutting edge of research and will impact the way we develop vaccines long-term," said Congressman Mike Castle. "Dr. Yusibov and his team are leaders in their field and we are lucky to have them here in Delaware."
“Receiving this competitive grant shows clearly that Fraunhofer is helping lead the way in creating vaccine technology that can protect us against dangerous threats such as bioterrorism and pandemic flu,” said Sens. Thomas Carper (D-Del.) and Edward (Ted) Kaufman (D-Del.). “We are proud of the work being done at Fraunhofer and look forward to seeing all that they will accomplish with this additional support from the federal government.”
About Fraunhofer USA Center for Molecular Biotechnology
Fraunhofer USA CMB, a division of Fraunhofer USA, Inc., is a not-for-profit research organization whose mission is to develop safe and effective vaccines targeting infectious diseases and autoimmune disorders. CMB’s technology provides a safe, rapid and economical alternative for vaccine production. The Center conducts research in the area of plant biotechnology, utilizing new, cutting edge technologies to assist with the diagnosis, prevention and treatment of human and animal diseases. The Center houses individuals with expertise and excellence in plant virology, pathology, molecular biology, immunology, vaccinology, protein engineering, and biochemistry. Further information is available at www.fraunhofer-cmb.org.
Contact:
Fraunhofer USA Center for Molecular Biotechnology
Dale Ervin, 302-369-3034
dervin@Fraunhofer-cmb.org
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