Ology Bioservices, a biologics contract development and manufacturing organization (CDMO), said 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 Robert House, senior vice president, government contracts, 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.
 
Peter Khoury, president and chief executive officer, Ology Bioservices, said, “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.