Large Molecules & Biologics

Laboratory Testing Excellence

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 with a broad service package from molecular biology, cell biology up to biochemistry, being a consistent partner in supporting manufacturer to fulfill several regulatory requirements. Development, set-up and validation, suitability, transfer and QC testing are daily work of our multidisciplinary and experienced team composed by more than 70 people.

Moreover capacity at already existing laboratory space has also increased in 2021, building new biologics GMP facilities able to fulfil BSL2 requirements, with about an additional 1000 m² of net BSL2 GMP laboratory. To date, this represents one of the biggest BSL2 facilities among the Eurofins BPT global network. The facilities are approved to facilitate testing Genetically Modified Microorganisms (GMMO) up to Level 2.