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 USD 130.3m, 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 programme 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 programme 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.
Technology Award: PRISM also awarded Ology Bioservices a USD 5.1m, 30-month contract entitled, "Developing, Establishing and Exercising Plasmid DNA Manufacturing Capabilities at the DOD Advanced Development and Manufacturing Facility."
Under this programme, 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 US government and commercial clients for various uses, including RNA vaccines.
The Duke Human Vaccine Institute 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.
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 US Army Medical Research and Materiel Command.
Ology Bioservices is a privately-held, full-service Contract Development Manufacturing Organization 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 said its 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. Ology Bioservices has 20 years of experience developing and manufacturing drugs and biologics for the US government, with over USD 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.
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