Drug modalities have grown increasingly complex over time: chemically derived small molecules were followed by biological medicines, and peptides, proteins, monoclonal antibodies, cell & gene therapy products are actually used more and more for prevention and/or treatment of diseases, including rare ones.
Biologics-based drugs have been increasing their market share over the last decade and according to many studies, global market size is expected to reach 750 billion USD in 2028, with a subsequent increased demand for manufacturing and testing processes outsourcing.
Eurofins BioPharma Product Testing Italy has been active in the testing of biologics for several years, and significantly invested in 2021 to increase capacity at its testing campus located in Milan, Italy, with the establishment of new laboratory space. Capacity at already existing laboratory space has also been increased, building new GMP facilities able to fulfil BSL2 requirements, with about an additional 1000 m2 of net BSL2 GMP laboratory space, now fully operational.
The investment has been deployed in two phases: a 300 m2 laboratory space has been established at warp speed and is fully dedicated to COVID-19 vaccine testing, active since early 2021. A new 700 m2 facility was also built and completed at the end of 2021. To date, this represents one of the biggest BSL2 facilities among the Eurofins BPT global network. The facility is approved to facilitate testing Genetically Modified Microorganisms (GMMO) up to Level 2 and is ready to host molecular and cell biology tests, as well as biochemistry analyses. More than 40 analysts are currently active in this area with ambitious growth plans for the upcoming years.
The facility comprises 11 testing rooms, with negative pressure cascades and H14 HEPA filtration, supporting a wide range of testing in microbiology, rapid sterility, mycoplasma, in vitro pyrogenicity, microbial identification, genetic sequencing, bioassays and viral safety, compendial chemistry testing, identification and quantification analysis, purity, impurities, contaminants, raw materials assessment, and physicochemical characterisation.
Thanks to the new fully dedicated GMP and GMMO BSL2 facility, Eurofins BioPharma Product Testing Italy can support biopharmaceutical companies throughout the biologic lifecycle from analytical method development to marketed product release analysis with drastically increased capacity.
