Therapy Areas: Vaccines
Ology Bioservices Awarded USD 37m by Department of Defense for Advanced Development of Anti-COVID-19 Monoclonal Antibody Cocktail
23 November 2020 - - The US Department of Defense has awarded US-based biologics contract development and manufacturing organisation Ology Bioservices Inc. (Ology Bio) an agreement valued at USD 37m, the company said.

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 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 filing and ultimately marketing of ADM03820.

In addition, Ology Bio will support the DOD with a request for an Emergency Use Authorization and/or Expanded Access of ADM03820 for at-risk military personnel.

Ology Bio is a privately held, full-service Contract Development Manufacturing Organization serving both government and commercial clients, specialising 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.

Ology Bio has more than 20 years' experience developing and manufacturing drugs and biologics for the US government, with more than USD 1.8bn in government contracts awarded. The team at Ology Bio has decades of experience manufacturing, developing and licensing vaccines and protein/antibody therapeutics.