Quality Control: Biologics and Biosimilars

The Biopharmaceutical Analyses Department provides comprehensive analytical services to support the development, characterisation, and quality control of biologics and biosimilars. Our expertise covers a wide spectrum of molecules, including peptides, monoclonal antibodies, fusion proteins, and antibody–drug conjugates (ADCs).

We deliver post-production characterisation, potency assessment, quantification of biopharmaceuticals in biological matrices, immunogenicity testing, pharmacokinetic (PK) and statistical data analysis, and plasma protein binding studies. PK sample analysis is performed with high precision using either liquid chromatography–mass spectrometry (LC-MS) or ligand-binding assays (LBAs), depending on the molecule and required sensitivity.

All services are performed in full compliance with EMA, FDA, and ICH guidelines, ensuring scientifically robust and regulatory-compliant results that help bring safe biopharmaceutical products to market.