Alachua, Florida biologics contract development and manufacturing organization (CDMO), Ology Bioservices, Inc., announced this week 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).

Ebola image/NIAID
Ebola image/NIAID

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.

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“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.