Ology Bioservices, Inc., a biologics contract development and manufacturing organization (CDMO), announced today that the Department of Defense (DOD), through its Platforms for Rapid Integrated Solutions for Medical Countermeasures (PRISM) office, has awarded the company with two contracts valued at $135.4 million. The first is for the development of a medical countermeasure, and the second is to support the development of a new technology platform.
Medical Countermeasure Award: The PRISM Office awarded Ology Bioservices a $130.3 million, 10-year contract, entitled, “Development and Utilization of a Monoclonal Antibody Platform Prototype for Development of Monoclonal Antibodies as Medical Countermeasures Against Threats of Interest.” This program is part of PRISM’s Advanced Development and Manufacturing of Antibody Technologies (ADAMANT) platform concept, which is intended to explore how monoclonal antibodies can be used as next-generation medical countermeasures against chemical and biological threats.
The target for this program is Plague, a disease caused by infection with the bacterium Yersinia pestis (Y. pestis). Plague has been responsible for several major, deadly pandemics throughout recorded history. As the Plague is considered a potential biological weapon, the efforts of this program are focused on producing high quality monoclonal antibodies that will protect warfighters who may become exposed to this deadly agent.
“To date, no one has successfully used monoclonal antibodies against Y. pestis as a treatment for Plague in humans,” said Dr. Robert V. House, Senior Vice President, Government Contracts at Ology Bioservices. “This multiyear program, which will encompass solutions for discovery/design, manufacturing, testing, quality, regulatory strategy and program management, gives Ology Bioservices the unique opportunity to make meaningful strides in this arena. We have assembled a world-class team to assist us in this effort including the Duke Human Vaccine Institute, Just Biotherapeutics, Inc., Mapp Biopharmaceutical, Inc., the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID), Cato Research, Certara and Battelle.”
Technology Award: PRISM also awarded Ology Bioservices a $5.1 million, 30-month contract entitled, “Developing, Establishing and Exercising Plasmid DNA Manufacturing Capabilities at the DOD Advanced Development and Manufacturing Facility.”
Under this program, Ology Bioservices will develop and deliver a prototype manufacturing platform for the CGMP production of nucleic acids, primarily plasmid DNA for use as both Drug Substance and high-quality intermediate. Plasmid DNA is important, primarily for its use in DNA vaccines and gene therapy. The aim of the project is to more rapidly and efficiently deliver biodefense medical countermeasures to warfighters, with reduced developmental risk.
Dr. Peter H. Khoury, President and Chief Executive Officer of Ology Bioservices, noted, “We welcome the opportunity to bring this important, cutting-edge technology to our company. Not only does it support the important work we do with the DOD to provide protection to warfighters, it also increases our skillset to enhance the services already offered to our commercial clients.”
This contract also includes optional components that would facilitate the development of capabilities for manufacturing RNA, another area of potential value to the U.S. government and commercial clients for various uses, including RNA vaccines.
About the Duke Human Vaccine Institute
The Duke Human Vaccine Institute (DHVI) is a unique organization that comprises an interdisciplinary, interdepartmental research institute within Duke University. DHVI investigators conduct cutting edge basic and translational research to develop novel vaccines, therapeutics and diagnostics for HIV and other emerging infectious diseases that threaten the health of our world. DHVI is home to one of the twelve NIH-constructed Regional Biocontainment Laboratories in the United States which has a comprehensive safety and operations program to provide state-of-the-art Biosafety Level 2 and 3 facilities for priority pathogen research. DHVI innovations are accelerated to human use with an in house CGMP manufacturing facility and a vaccine and treatment clinical trials unit. For more information, visit the Duke Human Vaccine Institute’s website at www.dhvi.duke.edu.
USAMRIID is celebrating its 50th year of providing leading edge medical capabilities to deter and defend against current and emerging biological threat agents. The Institute is the only laboratory in the Department of Defense equipped to safely study highly hazardous viruses requiring maximum containment at Biosafety Level 4. Research conducted at USAMRIID leads to vaccines, drugs, diagnostics and training programs that protect both warfighters and civilians. Established in 1969, the Institute plays a key role as the lead military medical research laboratory for the Defense Threat Reduction Agency’s Joint Science and Technology Office for Chemical and Biological Defense. USAMRIID is a subordinate laboratory of the U.S. Army Medical Research and Materiel Command. For more information, visit www.usamriid.army.mil.[The information contained in this press release does not necessarily reflect the position or the policy of the Government and no official endorsement should be inferred.]
About Ology Bioservices, Inc.
Ology Bioservices is a privately-held, full-service Contract Development Manufacturing Organization (CDMO) serving both government and commercial clients, specializing in biologic drug substance manufacturing, from early stage through commercial product. The company has 183,000 square feet of manufacturing, process development and QA/QC space in its state-of-the-art, Department of Defense Advanced Development and Manufacturing Facility in Florida. The company’s infrastructure provides unique services to its clients, including full regulatory support from preclinical through licensure, clinical trial operational support and bioanalytical testing, as well as cGMP manufacturing up to Biosafety Level 3 (BSL3). Ology Bioservices has 20 years of experience developing and manufacturing drugs and biologics for the U.S. Government, with over $500M in government contracts awarded over that time. The team at Ology Bioservices has decades of experience manufacturing, developing and licensing vaccines and protein/antibody therapeutics. For more information, visit the company’s website at www.ologybio.com.
At Ology Bioservices, Inc.
Robert V. House, Ph.D.
Senior VP, Government Contracts
At Rx Communications Group, LLC
Melody A. Carey, 917-322-2571
President and Chief Executive Officer