Biovest International and the U.S. Army Medical Resaerch Initiative of Infectious Diseases (USAMRIID) penned a Cooperative Research and Development Agreement (CRADA) focused on the further development of Biovest’s hollow fiber perfusion bioreactors as a modular manufacturing platform for producing vaccines and drugs such as virus-like particles (VLPs) and antibodies against infectious disease biothreats such as Ebola and Marburg viruses.
The firm, which is majority owned by Accentia Biopharmaceuticals, says the collaboration will build on the positive influenza virus data generated under an existing CRADA with the Naval Health Research Center, which is evaluating Biovest’s flagship AutovaxID™ bioreactor system. The latest CRADA with USAMRIID aims to demonstrate application of the hollow fiber bioreactors for propagating infectious viruses for vaccine production, and validate the production of VLPs and virus-neutralizing antibodies.
“Biovest’s collaboration with USAMRIID is part of a large U.S. government priority investment to become fully prepared for the swift and efficient delivery of medical countermeasures to highly infectious agents including avian and swine influenza, and other emerging diseases,” comments J. David Gangemi, Biovest’s consulting media advisor at Clemson University.
Biovest’s flagship automated hollow fiber bioreactor is the AutovaxID system, a production platform for the scalable manufacture of difficult-to-produce biologics including monoclonal antibodies, cell culture vaccines, and therapeutics targeting highly infectious agents.
AutovaxID is a fully automated, self-contained and scalable system that employs a single-use, hollow-fiber bioreactor for cell expansion. The platform represents the production system used in the manufacture of Biovest’s lead personalized cancer vaccine, BiovaxID, which has been developed in collaboration with the National Cancer Institute. BiovaxID is undergoing Phase III evaluation as patient-specific therapeutic cancer vaccine against follicular nonHodgkin lymphoma, mantle cell lymphoma, and potentially other B-cell blood cancers. Earlier this month the firm said it aims to file for approval of BiovaxID for the treatment of follicular nonHodgkin lymphoma in Canada by the end of 2012. At the time Biovest said it was also engaged in prefiling meetings with regulatory authorities in other countries and territories, including Europe and the U.S.