Biovest International, Inc. announced on May 11 that construction has been completed its new BiovaxID-dedicated production suites. It is part of an expansion project within Biovest's 35,000 sq. ft. cell culture center in Coon Rapids, a suburb of Minneapolis.
Funding was provided by a public/private partnership with the State of Minnesota, the City of Coon Rapids and JMS Holdings, LLC.
This new production space will accommodate manufacturing for Biovest's late-stage, autologous, active immunotherapy for the treatment of non-Hodgkins lymphoma. BiovaxID was developed in collaboration with the National Cancer Institute, and Biovest is currently preparing for meetings with U.S. and international regulatory agencies to discuss the next steps in seeking approvals for BiovaxID based on positive Phase III clinical trial results.
"This is a key milestone as we are initiating the commissioning and validation processes with the facility currently undergoing comprehensive testing and review to ensure that the BiovaxID manufacturing 'clean rooms' are consistent with our standards of operational excellence and will satisfy the regulatory criteria of an FDA inspection," said Biovests President, Samuel S. Duffey. "Furthermore, I expect we will be producing BiovaxID vaccines in this new facility sometime this summer."
