Tag: comparability studies

“ICH Q5B: Ensuring Quality and Consistency in the Development of Biological Products”

Explore the significance of ICH Guidelines Q5B for biological products. Understand its role in ensuring global standards for the development, quality, and safety of biotechnological and biological products. Learn about product characterization, comparability studies, reference standards, and the global impact of these guidelines. Stay informed about the challenges and future perspectives in the dynamic landscape of biopharmaceuticals.