Xcellerex, Inc., along with three collaborators, has been awarded an $11 million Phase II contract by the Defense Threat Reduction Agency (DTRA) – Joint Science and Technology Office, Transformational Medical Technologies Initiative (TMTI), to develop technology for accelerated monoclonal antibody and vaccine manufacturing.

Xcellerex is collaborating with Dowpharma, 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 will use BioPharm Services’ systems integration, data management/process economics, and simulated event modeling technology.

The Phase II contract follows successful completion of the Phase I contract originally awarded by the Defense Advanced Research Projects Agency (DARPA). The first phase of the program, which met all manufacturing productivity and product quality goals, was aimed at developing a high efficiency bacterial expression system using Pfenex with the 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 productivity and speed of process optimization, including demonstration of scale-up and improved economics.

“We are very pleased to be awarded this contract, which recognizes the progress this team made in Phase I to build a foundation for ultra-fast, flexible, and portable biomanufacturing,” said Parrish Galliher, Xcellerex’s founder and chief technology officer. “We look forward to the next, very challenging phase of the program with DTRA/TMTI and to continuing the productive collaboration with Dowpharma, deltaDOT and BioPharm Services.”

Hank Talbot, Ph.D., Dow’s director of research and operations added, “This substantial funding from DTRA validates the team’s success in Phase I of the DARPA program and will enable Dow to continue to aggressively advance the Pfēnex Expression Technology platform to address the need for rapid, high quality and high titer expression of vaccines and monoclonal antibodies.”

“We are honored to serve as System Integrator and to support this important program for the protection of our military in the event of a biologic threat,” said Peter Latham, president of BioPharm Services Inc.

Andrew Sinclair, managing director of BioPharm Services, added, “We are proud to provide economic modeling, simulation and process knowledge management solutions to the AMP project. These systems are an integral part of the solution aimed at meeting the challenges of the project, validating our position as a leader in the field of bioprocess systems modeling providing economic models.”

Stuart Hassard, PhD, deltaDOT’s chief scientist, commented, “deltaDOT is delighted to be part of this continuing program to accelerate the manufacture of pharmaceutical molecules. We are proud that our advanced label-free technology forms a core analytical tool in the program and look forward to working in this excellent collaboration.”