The Department of Defense (DOD), through its Platforms for Rapid Integrated Solutions for Medical Countermeasures (PRISM) office, has awarded Ology Bioservices two contracts valued at $135.4 million.
The first contract award is for the “Development and Utilization of a Monoclonal Antibody Platform Prototype for Development of Monoclonal Antibodies as Medical Countermeasures Against Threats of Interest.”
This award, valued at $130.3 million over 10-years, is part of PRISM’s Advanced Development and Manufacturing of Antibody Technologies (ADAMANT) platform concept. ADAMANT explores 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. 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.”
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.
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.
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.