As products such as biotechnology products and biological-origin pharmaceuticals are provided in clinical practice, the development of the functional high-molecular-weight proteins of high value—including modified antibodies— attracts attention. In contrast to synthetic pharmaceuticals, the structure of such proteins is heterogeneous, due to post-translational modification. The ICH Q6B states some requirements; for example, “extensive and detailed characterization should be performed in the development phase” and “manufacturers should define the pattern of heterogeneity of the desired product.” The ICH guideline specifies that “the development of new analytical technology and modifications to existing technology are continually being promoted.” It is clear that the proper utilization of technology to characterize products in a comprehensive and systemic fashion and some know-how for characterization can directly contribute to appropriate product evaluation and to the pace of drug discovery.
Waters® is developing a wide variety of solutions based on the bio-inert UPLC system, specified columns, QTof, simple mass detector and other data analysis technologies by making full use of our experience and know-how in life sciences. Here, we will introduce solutions for the characterization and monitoring of protein-based pharmaceutical products, practically used by many of our ACQUITY UPLC M-Class System with HDX technology: Developed for proteint conformational study and interaction site analysis of protein complex ACQUITY UPLC M-Class System with 2D technology: Designed for identificationand quantification of host cell proteins in biotherapeuties Gradient elution based on pH and salt concentration, and with an inert flow path and Auto-Blend Plus™ Technology to make blends from four types of solvents product evaluation and to the pace of drug discovery customers.