Quality by design (QbD) was a hot topic at IBC’s BioProcess International Conference and Exhibition, 20–24 September 2010 (Providence, RI). For her keynote address, Helen Winkle (director of the FDA’s Office of Pharmaceutical Science) discussed the agency’s continuing efforts to improve product quality regulation as well as opportunities and challenges of implementing QbD for biotechnology products (1). Since introducing its 21st Century Initiative in 2002, the FDA has made some headway toward enhancing product quality through QbD (2). The QbD…