Advaxia Biologics (formerly Advent), part of the IRBM group, is a cGMP Contract Development & Manufacturing Organisation (CDMO), located near Rome (Pomezia) Italy, compliant with the regulatory guidelines of the EMA, MHRA and FDA.
Advaxia’s integrated contract services portfolio includes outstanding support in the areas of analytical method development, process development/validation, in-process assay development & qualification, GMP Manufacture, full QC product release, ICH Stability and cell banking.
Advaxia’s multi-product facility consists of 8 independent classified rooms, including media prep/dispensing (2), 3 viral processing rooms, 1 cell culture and 2 fill/finish suites. Our facility is designed to provide maximum flexibility and continuity in the manufacturing process. All suites are state-of-the-art classified grade C areas with the exception of the grade B fill/finish rooms.
Advaxia is dedicated to the development and production of clinical lots of recombinant adenoviruses to support clinical trials for vaccine and gene therapy applications. The Advaxia team has built an outstanding track record in the production of clinical lots for many infectious diseases, including Ebola, HIV and supported the global effort to expedite delivery of a COVID-19 vaccine.