分析法QbDを活用したバイオ医薬品の分析法開発に関するケーススタディ

抄録

Analytical Quality by Design (QbD) is the science and risk-based approaches for developing and maintaining analytical procedures, those are suitable for the evaluation of the quality of drug substances and drug products. The basic principle of analytical QbD was established and harmonized in ICH Q14 guideline as an enhanced approach, however, the examples for implementation of analytical QbD for biopharmaceuticals are limited. Therefore, as a part of the advancement of quality control through the application of analytical QbD, we conducted case studies focusing on target analytical profile (ATP) setting and risk assessment to show specific examples of analytical procedure development for biopharmaceuticals. Regarding ATP setting, we focused on high molecular weight species/fragment, host cell protein (HCP), and biological activity as representative quality attributes of biopharmaceuticals. As analytical techniques to measure each quality attribute, size exclusion chromatography was selected for high molecular weight/fragment, enzyme-linked immunosorbent assay (ELISA) for the total amount of HCP, and binding ELISA for biological activity were selected. While the examples shown in the ICH Q14 Annex are mainly described assuming the time of application for approval, this case study is characterized by considering issues to be considered from the early stages of drug development. It is expected that analytical QbD will be utilized for biopharmaceuticals, and that appropriate development and life cycle management of analytical procedures will be carried out.