Xcellerex, Collaborators Receive $11M Phase 2 U.S. Contract To Develop Technology For Accelerated Monoclonal Antibody And Vaccine Manufacturing
Xcellerex, Inc. announced recently that the company, along with three collaborators, has been awarded an $11M Phase 2 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.
The Phase 2 contract follows successful completion of the 12-month Phase 1 contract originally awarded by the Defense Advanced Research Projects Agency (DARPA). The initial contract met or exceeded all manufacturing productivity and product quality goals.
Xcellerex, which serves as the prime contractor, is collaborating with Dowpharmasm, 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.
"We are very pleased to be awarded this contract, which recognizes the progress this team made in Phase 1 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."
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 2 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 1, with the added objective of increasing product quality.
Hank Talbot, PhD, 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 Pfenex 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, LTD 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."
About DTRA and TMTI
DTRA is the intellectual, technical and operational leader for the Department of Defense (DoD) and the U.S. Strategic Command in the national effort to combat the weapons of mass destruction (WMD) threat. The ultimate goal of TMTI is to develop a long-term, sustained capability to rapidly respond to a novel biological threat by integrating all aspects of response, from identification through the development and manufacturing of new medical countermeasures.
About Xcellerex, Inc.
Xcellerex is revolutionizing the way biomolecules are developed, manufactured, and commercialized. The company's unique single-use component technology platform transforms biomanufacturing economics, enabling the development of biotherapeutics and vaccines, and dramatically improving the ability of Xcellerex and its partners to deploy manufacturing capacity. Xcellerex leverages its technology and services platform by: 1) commercializing its FlexFactory™ biomanufacturing platform (complete, turnkey, modular production trains) and XDR (unique, single-use component bioreactor systems); 2) building a portfolio of proprietary biotherapeutics and vaccines through creative alliances and in licensing; and 3) creatively structuring transactions around FlexFactories, XDRs and its pipeline.
About Dowpharma and Pfenex Expression Technology™
Dowpharma provides the pharmaceutical and biopharmaceutical industries with innovative technologies, products and services for clients in drug discovery, development, manufacturing and delivery. Pfenex Expression Technology™ includes an extensive toolbox of gene expression capabilities and multiple host strains. Combined with high-throughput methods, strains producing high levels of active, complex recombinant proteins such as antibody derivatives and fully-functional antigens and adjuvant proteins are rapidly constructed and identified. The production process contains no animal derived products and no antibiotics or antibiotic selection markers, making scale-up safe, efficient, and highly cost effective.
About BioPharm Services
BioPharm Services is a technical consultancy dedicated to helping clients in the biopharmaceutical manufacturing sector to reduce costs, understand their markets, improve productivity and reduce their time to market. The company offers a range of specialist services including program management and business development services from the US office and economic analysis with their BioSolve package and custom cost models, process simulation (BioSim), facility design and design for disposables from the UK operation. For more information visit www.biopharmservices.com.
About deltaDOT Ltd
deltaDOT is a biotechnology company that is developing and commercializing highly innovative enabling technologies and products in the bioscience arena. The company was founded in 2000 and is a spin-out from Imperial College London, UK. It is focused on the harnessing of cutting-edge particle physics technology and its application to the needs of biomolecular separation, including proteins, DNA and RNA analysis. The company has a strong proprietary position and extensive expertise in instrumentation, micro-fluidics, automation, computing and analysis which will contribute to improvements in knowledge, profitability and process time throughout drug discovery and general life sciences research. For more information visit www.deltadot.com