ALACHUA, Fla.–(BUSINESS WIRE)–Ology Bioservices Inc. (Ology Bio), a biologics contract development and manufacturing organization (CDMO), announced today that the Department of Defense (DOD) has awarded the company with an agreement valued at $37 million. This work is supported by the Office of the Assistant Secretary of Defense for Health Affairs with funding from the Defense Health Agency.
The scope of this program includes the activities required to rapidly develop, manufacture, and obtain FDA licensure of a monoclonal antibody (mAb) cocktail (ADM03820) that was originally identified in a previous agreement with the DOD. The regulatory strategy will outline the manufacturing process characterization and validation activities required to support the initial Biologics License Application (BLA) filing and ultimately marketing of ADM03820. In addition, Ology Bio will support the DOD with a request for an Emergency Use Authorization (EUA) and/or Expanded Access (EA) of ADM03820 for at-risk military personnel.
“This award will allow Ology Bio to extend our rapid development and manufacturing capabilities by introducing the critical regulatory component,” said Peter H. Khoury, Ph.D., President and Chief Executive Officer of Ology Bio.
About Ology Bioservices Inc.
Ology Bio 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 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 Bio has more than 20 years’ experience developing and manufacturing drugs and biologics for the U.S. government, with more than $1.8 billion in government contracts awarded. The team at Ology Bio 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.
[The information contained in this press release does not necessarily reflect the position or the policy of the U.S. government and no official endorsement should be inferred.]