Xcellerex, a developer and marketer of biomolecules, along with three collaborators, has received an $11 million Phase II contract from the Defense Threat Reduction Agency – Joint Science and Technology Office, Transformational Medical Technologies Initiative, to develop technology for accelerated monoclonal antibody and vaccine manufacturing.
The Phase II contract follows successful completion of the 12-month Phase I contract originally awarded by the Defense Advanced Research Projects Agency (DARPA). The initial contract met or exceeded all manufacturing productivity and product quality goals.
The first phase of the program was aimed at developing a high efficiency bacterial expression system using Dowpharma’s Pfenex Expression Technology in conjunction with Xcellerex’s single-use FlexFactory platform to grow production strains to high cell densities and to purify the model vaccine and antibody.
The Phase II effort is focused on increasing the productivity and speed of process optimization, including demonstration of scale-up and improved economics. This work will include optimizing host strains and a manufacturing process required to increase the yield of vaccine and monoclonal antibody by 10-fold over that achieved in Phase I, with the added objective of increasing product quality.
Xcellerex, which serves as the prime contractor, is collaborating with Dowpharma, a business unit of the Dow Chemical Company, Biopharm Services, and deltaDOT. The team combines Xcellerex’s microbial PDMax high speed process development and FlexFactory single-use manufacturing technologies with Dowpharma’s Pfenex Expression Technology and deltaDOT’s Peregrine label free CE-based analytical technology. The team is guided by BioPharm Services systems integration, data management/process economics, and simulated event modeling technology.
Hank Talbot, Dow’s director of research and operations, said: This substantial funding from Defense Threat Reduction Agency validates the team’s success in Phase I of the DARPA program and will enable Dow to continue to aggressively advance the Pfenex Expression Technology platform to address the need for rapid, high quality and high titer expression of vaccines and monoclonal antibodies.