ALACHUA, Fla.--(BUSINESS WIRE)--Ology Bioservices, Inc., a biologics contract development and manufacturing organization (CDMO), announced today that it was awarded an Other Transaction Agreement (OTA) to support the Joint Project Manager Medical Countermeasure Systems (JPM-MCS), a component of the Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO CBRND) for advanced biologics manufacturing services—specifically, to manufacture an anti-Ebola monoclonal antibody (mAb). The award was made possible through collaborative funding between JPEO CBRND and the Defense Advanced Research Projects Agency (DARPA). The antibody, designated mAb114, was developed at the Vaccine Research Center (VRC), part of the National Institute of Allergy and Infectious Diseases (NIAID) with the National Institutes of Health, in part through funding previously provided by DARPA. The VRC is a collaborator with JPM-MCS, DARPA, and Ology Bioservices on this program. Including optional work, the agreement has a value of $8.4 million.
Ebola is a rare and deadly disease endemic to Africa; it has been identified as a potential biothreat agent by the U.S. Department of Defense (DoD). Under terms of the contract, Ology Bioservices will perform technology transfer of the Ebola mAbs production process into the Department of Defense Advanced Development Manufacturing Facility (DoD ADM). The DoD ADM Facility is a 183,000-square foot, state-of-the-art, multi-purpose, multi-product, Biosafety Level 3-capable facility operated by the company in Alachua, Florida. The product will be produced using cGMP manufacturing at a volume of 500 L and is expected to be delivered in December 2018. The agreement includes an option for two additional manufacturing lots to be delivered in early 2019.
“Given the inherent danger posed by Ebola to the global population, there is an urgent need to mitigate future outbreaks by ensuring rapid and efficient manufacturing and delivery of a protective countermeasure. Based on our successful work with other important biologics countermeasures, we are pleased to have been selected by the DoD to provide this critical product,” stated Peter H. Khoury, Ph.D., MBA, President and Chief Executive Officer of Ology Bioservices.
About Ebola Virus Disease
The Ebola virus was first discovered in 1976 near the Ebola River in what is now the Democratic Republic of Congo. It is a rare and deadly disease in both people and nonhuman primates (monkeys, gorillas, and chimpanzees). Scientists believe that people are initially infected with Ebola through contact with an infected animal. Once in humans, the virus spreads through direct contact with bodily fluids of a person who is sick with, or, has died from Ebola.
The highly publicized 2014-2016 Ebola outbreak in West Africa began in a rural setting of southeastern Guinea, spread to urban areas and across borders within weeks, and became a global epidemic within months, killing more than 11,000 people in West Africa, alone. Most recently, on May 8, 2018, the Democratic Republic of Congo’s health minister declared another Ebola outbreak.
Current treatment of patients with suspected or confirmed Ebola infection includes quarantine, symptom management, and supportive care, since there are no approved vaccines or treatments yet available for human use. Meanwhile, studies of patients treated with convalescent plasma and monoclonal antibodies have yielded encouraging results.
About Ology Bioservices
Ology Bioservices is a 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.
