QbD for Biotechnology Products, Where are We Now?
*Kathy Lee, FDA 


The implementation of Quality by Design (QbD) has been talked about for many years in the pharmaceutical industry. Only in the last few years have submissions to the Food and Drug Administration (FDA) included implementation of QbD principles. This is especially true for biologics applications. However, the QbD pilot programs initiated by both the Office of New Drug Quality Assessment and the Office of Biotechnology Products have helped industry and the FDA understand the practical implementation of QbD. This talk will focus how QbD principles have been applied for biologic products submitted for review at the FDA and the challenges for not only industry but the FDA to understand and evaluate these applications.