BARDA and the Department of Defense’s Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) are partnering with Ology Bioservices (Ology Bio) to expand the capacity for filling and finishing vaccines and therapeutics in the United States.
Filling and finishing vials are the last two steps in the manufacturing process for vaccines and drugs. With this award to Ology Bio, the U.S. government helps to ensure that the country will have enough domestic capacity to complete these critical final steps to make vaccines or therapeutics available to the American people. As part of this agreement, the federal government will hold a reservation for 24 hours a day 7 days a week fill/finish capacity production on commercial filling lines for use by federal partners that are developing COVID-19 vaccines or therapeutic treatments.
Historically, vaccine product developers have contracted directly with fill finish facilities for their needed fill finish services. The U.S. government is reserving this capacity directly to ensure BARDA-sponsored product developers and manufacturers have timely access to this capacity for the COVID-19 response.
About Ology Bio:
The following information is provided by the company and does not indicate an endorsement by the federal government of the company or its products.
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 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 more than 20 years of experience developing and manufacturing drugs and biologics for the U.S. government, with over $1.8 billion in government contracts awarded.