ABL Awarded BARDA Contract to Fill Live Virus-Based Medical Countermeasures
ABL, Inc. (ABL), a global contract research and manufacturing service provider to the U.S. Government and biopharmaceutical industry, announced today it has been awarded a five-year, indefinite delivery/indefinite quantity (ID/IQ) contract #HHSO100201600019I entitled “Respiratory Illness Live Virus Fill/Finish Services” by the Biomedical Advanced Research and Development Authority (BARDA) within the Office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services (HHS).
The contract has a maximum ordering amount of $50 million and is part of a multiple award network to provide fill/finish capabilities for live virus-based medical countermeasure (MCM) product development towards licensure. ABL will utilize its GMP facilities located in Rockville, MD and Strasbourg, France, each site staffed with manufacturing, bioanalytical and quality assurance teams with extensive experience producing vaccine, therapeutic and diagnostic products.
“We are very excited to be supporting BARDA and ASPR for the rapid development and manufacture of vaccines and therapeutics against potential pandemic and emerging disease targets,” said Dr. Thomas VanCott, President and CEO of ABL. “ABL provides bulk and filling capabilities specifically designed to handle live virus products, and with facilities in Europe and the U.S., we are ideally positioned to meet BARDA’s MCM requirements.”
ABL’s fill and finish drug manufacturing capabilities meet U.S. FDA and European GMP requirements for a wide variety of live/vectored products at pilot, clinical, and commercial scales. Our infrastructure and expertise provides BARDA with the rapid response times and flexible resources required during a public health emergency. Our comprehensive services ranging from development to GMP to regulatory support, means that our clients can be assured of a smooth transition as their product advances through preclinical and clinical phases with the highest level of quality and technical expertise.
ABL, Inc. is a global biomedical contract research and manufacturing organization dedicated to advancing therapeutics, vaccines and other biologic products. ABL maintains GMP facilities meeting U.S. and European regulatory standards, providing process and assay development, cGMP manufacturing of bulk drug substance, cGMP aseptic fill and finish of drug product, and QC bioanalytical testing. Our U.S. and European immunological and molecular laboratories support clients’ preclinical and GCLP clinical sample processing and testing needs. ABL is a part of the Institut Mérieux, a group of companies dedicated to developing translational science for better patient care globally.
The Biomedical Advanced Research and Development Authority (BARDA), within the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services, provides an integrated, systematic approach to the development and purchase of the necessary vaccines, drugs, therapies, and diagnostic tools for public health medical emergencies. BARDA develops and procures needed medical countermeasures, including vaccines, therapeutics, diagnostics, and non-pharmaceutical countermeasures, against a broad array of public health threats, whether natural or intentional in origin.