Protech Pharmaservices Corporation, Taiwan
Title: The use of high-speed liquid chromatography/Tandem mass spectrometry in the GLP assays for biosimilars
Yunsheng Hsieh received his Ph.D. from Chemistry Department of Michigan State University. During his tenure at Drug Metabolism and Pharmacokinetics (DMPK) Department of legacy Schering-Plough Research Institute/Merck Research Laboratories, he lead a strong bioanalytical group to apply challenging UPLC-MS/MS approaches for metabolite identification and sub-nanogram/ml quantitative assays of a variety of molecules and also served as a project manager to conduct in vitro and in vivo exploratory DMPK experiments for a variety of drug discovery programs such as TRA, HCV, CHK1 and to present the results in collaboration with medicinal chemistry and biology departments to support drug discovery projects.
Biosimilars development demands rapid and reliable bioanalytical methods across preclinical and all phases of clinical trials to assess the similarity in the pharmacokinetic/ pharmacodynamic outcomes. Fast liquid chromatography coupled to tandem mass spectrometry (LC-MS/MS) has become the most widely employed bioanalytical technique in quantitative determination of small molecules. In this presentation, we discuss our strategies in extending the use of high-speed LC-MS/MS approaches to biosimilars assays under good laboratory practice (GLP)-compliant setting. The impact of sample preparation methods such as protein precipitation, solid-phase extraction and immuno-precipitation prior to chromatographic separation on assay sensitivity, selectivity, accuracy will be presented. The results obtained by the proposed method were compared with those obtained by ligand-binding assays.