Advaxia Biologics (formerly Advent) is a cGMP Contract Manufacturing Organization (CMO), located in Pomezia within the IRBM campus.
The facility consists of five independent production rooms, a media prep room, a storage area, a purification room and a fill/finish suite. It is designed to provide maximum flexibility and continuity in the manufacturing process. All laboratories are state-of-the-art classified grade C areas with the exception of the grade B fill/finish suite.
We operate in full compliance with the guidelines of the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the Italian National Regulatory Authority (AIFA). We are authorized for manufacturing and testing of investigational medicinal products and testing of human medicinal products (commercial AZD1222 vaccine). We are also ISO 14.001 and ISO 45.001 certified.
Advaxia is trusted by transformative pharmaceutical companies throughout the world. We have developed and manufactured an Ebola Virus Vaccine for GlaxoSmithKline, served as a testing site for AstraZeneca’s COVID-19 vaccine, and produced COVID-19 clinical batches — and we continue to break new ground in the creation of adenovirus-based vaccines.
Altogether, we have helped prepare regulatory dossiers for more than 50 pharmaceutical products, spanning a variety of regulatory authorities and government entities throughout the United States, Europe, ASIA and Canada.