ALACHUA, Fla.–(BUSINESS WIRE)–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
“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.
VP, Government Contracts
At Rx Communications Group, LLC
Melody A. Carey, 917-322-2571
and Chief Executive Officer