Abstract

Application of QbD Principles in Biologics Drug Product Development

Satish Singh, Head, Lonza Inc

Quality by Design (QbD) is a global regulatory initiative with the goal of enhancing pharmaceutical development through the proactive design of pharmaceutical manufacturing process and controls to consistently deliver the intended performance of the product. Product development under QbD paradigm requires a systematic approach and an integrated set of tools that enables the assessment of key QbD elements including identification of critical quality attributes, classification of manufacturing process parameters according to their criticality, and definition of the control strategy.  A series of risk assessments guides the studies required to generate data / capture knowledge in a systematic manner throughout the development process. The presentation will provide examples of tools that cover some of these elements.