Abstract

Implementation of QbD for Biopharmaceuticals: Tools and Case Studies

Anurag Rathore, Professor, Indian Institute of Technology Delhi

Quality by Design (QbD) started gaining momentum in the biotech industry after publication of the FDA’s PAT - A Framework for Innovative Pharmaceutical Manufacturing and Quality Assurance1-3. While the underlying concepts are becoming clear and widely accepted, the realization that technological advancements are necessary to facilitate QbD implementation is also dawning on the industry. This talk will focus on some of the tools that play a critical role in implementation of QbD for biotech processes. Real case studies have been used to elucidate this. Tools that will be discussed include Process Analytical Technology (PAT), multivariate data analysis (MVDA), design of experiments (DOE), high throughput process development (HTPD), mechanistic modeling and computational fluid dynamics (CFD). Work on these topics that is being performed in our laboratory will be presented.