JAIMA - Analytical Solutions for Research, Development & CMC of Novel Modalities of Drugs: Comprehensive Understanding of Molecular Structure, Dynamics and Function

In this morning session, at 8:30 am, Kohei Tsumoto, from The University of Tokyo, and Hiroyuki Kanda, Chief of the Life Science Committee of JAIMA, presided over the session. The topic of the presented talks involved the need for new methods for the analysis and monitoring of each process from R&D to production of new drug modalities, such as next-generation antibody drugs and nucleic acid drugs. To meet such needs, data science, including AI and machine learning, is being explored to bring new knowledge for understanding of the structure, dynamics, and function of molecules, and for improving the efficiency of drug discovery and research. This session discussed projects for developing analytical solutions for the pharmaceutical market using new data science improvements. The session was held in America/Toronto, Room 121C.

At 9:10 am, Noritaka Hashii of the Division of Biological Chemistry and Biologicals at the National Institute of Health Sciences presented the use of the multi-attribute method (MAM) for the evaluation of structural characteristics of therapeutic antibodies. This presentation described major modifications of therapeutic monoclonal antibodies (mAbs) characterization and research by the application of MAM analysis.

At 9:45 am, Forrest Kohl, an Application Scientist at JASCO specializing in electronic spectroscopy, gave his talk on an innovative solution for higher-order structure assessment of biopharmaceuticals combining spectroscopy with machine learning and statistical methods. An innovative solution was proposed for the structural analysis of therapeutic antibodies using a new structure estimation algorithm, a spectral similarity evaluation methodology, and Fourier transform infrared (FT-IR), Raman, fluorescence, and ultraviolet-visible (UV-vis) spectroscopy measurements.

At 10:35 am, Zachary Breitbach from AbbVie, Inc. gave a talk on advancing compact liquid chromatography (LC) for elucidating process understanding and for automating analytical instrumentation for biopharmaceutical research and development work. This presentation reported on the development of the Enabling Technologies Consortium (ETC) collaborative advanced compact LC, which is approximately the size of a shoebox, and which was developed by eight pharmaceutical companies partnering with an instrumentation development group. This instrument demonstrated the concept of “sample in – data out” capabilities.

At 11:10 am, Yi-chieh Chen, a Lecturer in the Department of Chemical Engineering at the University of Strathclyde, presented work to develop a spatially resolved spectroscopy (SRS) probe for inline monitoring of the drying process in pharmaceutical drug processing. The talk discussed the developed of an integrated inline Process Analytical Technology (PAT) solution that uses SRS to collect complementary Raman and NIR spectra to determine the sub-surface chemical and physical information for drug samples during production.

The session concluded at 11:45 am.