This Monday morning session will be presided over by Arindam Roy of Novartis Consumer Health. It will show how leading scientists use chromatography and mass spectrometry in the development of both the traditional pharmaceuticals — where the active ingredient is a small molecule — and biopharmaceuticals — where the active ingredient is a large-molecule protein or monoclonal antibody (mAb).
The first two talks will cover small-molecule pharmaceuticals. David K. Robbins of Eli Lilly will discuss the use of these methods for the analysis of trace impurities of toxicological concern. Next, Roy will talk about developing, validating, and transferring methods for quality control of drug products.
The next three presentations will cover large molecules. Taylor Yonghua Zhang of Genentech will address how to decipher unknown peaks in HPLC for the analysis of mAbs. The characterization of protein therapeutics by mass spectrometry will be the subject of the following presentation, by Li Tao of Bristol-Myers Squibb. To close the session, Isabel Feuerstein of Sandoz will discuss the extensive characterization of biosimilars using chromatography and mass spectrometry.