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Facilitating use of Quality by Design concepts in regulatory submissions

Patrick G Swann

In 2008, the Office of Biotechnology Products (OBP) at the US FDA initiated their Quality by Design (QbD) pilot program. The program was designed to define clinically relevant attributes for protein products regulated by the OBP and link them to manufacturing processes. As a supervisor within the OBP, I was fortunate to participate in the review of many of the submissions to the pilot program and comment upon many different approaches from the pharmaceutical/biotechnology industry. Almost without exception, the companies that participated in the OBP pilot program shared with the FDA impressive scientific presentations communicating their efforts to enhance biotechnology product and process understanding. Having recently left the FDA and now being able to look back and reflect, I would like to provide my personal perspective on the current state of QbD implementation as well as provide a few modest proposals to address some of the known regulatory issues.