11^th European Biosimilars Congress

Regulatory requirements for biosimilars include process related impurities including (HCP) which should be identified, characterized as appropriate, quantified, and compared with the reference products. Here we present a HCP analysis method based on a SWATH (Sequential Windowed Acquisition of All Theoretical Fragment Ion Mass Spectra) LC-MS workflow that is fast, sensitive and provides reproducible identification and absolute quantification of individual HCP’s in the purified drug substance. The workflow is generic for vaccines, mAbs (monoclonal antibodies), small therapeutic proteins and protein biopharmaceuticals. We will present this new method for accurate and absolute HCP quantification, and parameters critical for method validation, including reproducibility, linearity, LOD/LOQ and measurement range. Case examples will be shown including comparison between biosimilar and originator product.