(332f) Analytical QbD for Biologics

Quality by Design (QbD) for Analytical Development is a systematic approach to identify and develop analytical methodologies which is suitable for the intended purpose.  This process consists of various steps and starts with defining an Analytical Target Profile (ATP) based on molecular characteristics, process understanding and thus identifying the Critical Quality Attributes (CQA).  At the heart of this approach is proper Design of Experiments (DOE) studies to understand method variability and to establish method parameters which provide desirable method performance.  This talk discusses these elements and challenges of QbD as it applies to analytical development for biologics and also solution and approaches to address them.