Symposium Sessions
Day 1, June 10（Wed.） 13:50-14:20 Room A (5F 503)
- 1A-S1-1350
Current trend in development of pharmaceuticals - Usefulness of mass spectrometry in characterization, quality control and bioanalysis in their development -
(Natl. Inst. Health Sci.)
oAkiko Ishii-watabe, Noritaka Hashii
The trends in drug development have evolved over time, reflecting advances in drug discovery and manufacturing technologies. Historically, small-molecules and biopharmaceuticals (i.e., recombinant therapeutic peptides and proteins) had been two major modalities. However, attention has shifted to other new modalities. These include chemically synthesized medium-sized molecules such as oligonucleotides and peptides, gene therapy products like viral vectors, and cell therapy products. Furthermore, development of engineered antibodies (e.g., antibody-drug conjugates) is also expanded and they are also considered as a part of new modalities. The new modalities usually have complex structure, and more sophisticated analytical technologies are required during product development. Liquid chromatography-mass spectrometry (LC-MS) plays a crucial role in their development, particularly in quality evaluation and also in bioanalysis performed during nonclinical and clinical studies.
In this presentation we will provide an overview of the evolution and current status of pharmaceutical modalities, along with the importance of mass spectrometry in their development. Additionally, we will introduce our current efforts in standardizing multi-attribute methods for characterization and quality control of therapeutic monoclonal antibodies and in the bioanalysis of ADCs, aiming to discuss further applications of mass spectrometry.