The biomanufacturing industry’s increasing attention to risk mitigation through quality by design (QbD) and the emergence of complex therapeutic modalities have driven the need for a lifetime-management approach to assuring drug product stability. To that end, industry guidelines have been (or are being) developed to guide the industry toward a “holistic approach” to conducting stability assessments. However, not all methods are stability indicating, and many more industry concerns need to be addressed.
This BPI eBook offers perspectives on ICH Q12 guidelines and the upcoming USP <1049.1> general chapter. It also surveys advancements in analytical technologies that could provide better drug product stability testing.