Quality By Design: A Holistic Approach To Drug Development

By Anil Kane, Ph.D., MBA, Executive Director, Global Head of Formulation Development; Kaspar van den Dries, Ph.D., Senior Director and Principle Scientist Solid Dose Development; Douglas Rufino, VP Global Corporate Quality, Pharmaceutical Development Services, Thermo Fisher Scientific

As the biopharmaceutical industry continues to evolve, the Quality by Design (QbD) holistic and proactive approach to drug development and manufacturing is transforming key processes. In response to increased interest from global regulatory agencies, QbD seeks to further reduce the risk associated with drug development and bring much-needed therapies to market quicker.

Sponsors who implement QbD early can save money through increased product/process knowledge, less re-work, less product deviation, less product out-of-specification, fewer rejects and improved quality.

While QbD evolves from good practice to agency requirement, how can sponsors ensure that rigorous, scientific risk-based approaches are used to bring better and safer therapies to market faster? To realize the full potential of this investment, QbD must link early- and late-stage development with manufacturing and commercialization. Most importantly, applying QbD ensures a quality product reaches patients.