Xcellerex, Collaborators Receive $11 Million Phase 2 U.S. Contract to Develop Technology for Accelerated Monoclonal Antibody and Vaccine Manufacturing
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MARLBORO, Mass.--(Business Wire)--
Xcellerex, Inc. announced today 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 Pfēnex Expression TechnologyTM 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 Pfēnex 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 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, 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. Learn more at www.xcellerex.com.
About Dowpharma SM and Pfēnex Expression Technology
DowpharmaSM provides the pharmaceutical and biopharmaceutical industries with
innovative technologies, products and services for clients in drug discovery,
development, manufacturing and delivery. Pfēnex 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. For more information about Dowpharma visit www.pfenex.com
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. See
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.
Find out more about deltaDOT Ltd at www.deltadot.com
®TM Trademark of The Dow Chemical Company ("Dow") or an affiliated company of
Dow
SM Service Mark of The Dow Chemical Company
® Registered trademark of deltaDOT Ltd, London United Kingdom
Xcellerex, Inc.
Parrish Galliher, 508-480-9235
President and Chief Technology Officer
or
RMG Associates, LLC
Robert Gottlieb, 857-891-9091
Copyright Business Wire 2009
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