[WS7] Analysis, quality control and regulatory science of biopharmaceuticals and viral vectors for gene therapy

[WS7-01] Current status and issues on evaluation of protein aggregates/subvisible particles in biopharmaceuticals from regulatory perspective

^○Hiroko Shibata, Masato Kiyoshi, Akira Harazono, Akiko Ishii (DBCB, NIHS)

For the characterization and quality control of biopharmaceuticals, the use of state-of-the-art analytical technologies are desirable due to the complexity of molecular structure. Basically, it is necessary for each company to develop and validate these analysis methods. Therefore, standardization of fundamental methodologies used for quality evaluation of biopharmaceuticals will decrease the resources for the method development process, and promote efficient drug development. From this background, we have been conducting the collaborative study on development and standardization of the common fundamental methodologies used for quality assessment of biopharmaceuticals, especially focusing on the evaluation method of aggregates/subvisible particles. As aggregates/subvisible particles may have a substantial impact on immunogenicity, the evaluation of aggregates/subvisible particles in biopharmaceuticals has been of great interest for both pharmaceutical manufacturer and regulatory agency. In this presentation, we will summarize challenges for the evaluation of aggregates/subvisible particles and show our resent achievements from the collaborative study.