The Fraunhofer USA Center for Molecular Biotechnology (CMB) received $4.395 million from DARPA to fund Phase I trials with its H1N1 flu vaccine candidate. The grant represents the third tranche of funding received from DARPA for the development of CMB’s plant-based production system, the center states.
The latest DARPA money follows on from the March 2009 receipt of a $12 million phase 1 DARPA award under the agency’s Accelerated Manufacture of Pharmaceuticals (AMP) program. The funded research was designed to culminate in the demonstration that CMB’s plant-based manufacturing system can rapidly produce safe, effective vaccines against any rapidly emerging threat agent.
In 2008, the Fraunhofer CMB AMP team successfully completed optimization and feasibility studies under the DARPA phase 1 program. The firm also finished construction of a cGMP pilot manufacturing facility at the end of 2009.
“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,” comments Vidadi Yusibov, Ph.D., executive director of Fraunhofer USA CMB. “While the production platform has been validated by extensive preclinical studies, we are looking forward to entering the clinical phase of development.”
The AMP program is focused on the development of novel biological expression platforms capable of producing life-saving medical countermeasures quickly enough to be effective against rapidly emerging biological threat agents such as pandemic flu and anthrax biological weapons.