title: The Evolution of quality by design (QbD) for biologics.
abstract: In recent years, regulators have recognized the need for more controls in drug manufacturing processes. Quality by design is a science- and risk-based approach to drug product development and several pilot programs are ongoing to evaluate enhanced drug development strategies. This article provides a commentary on a recent regulatory publication on the subject of design space verification.
authors.affiliation: Principal Consultant, PAREXEL International, Uxbridge, Middlesex, UK anthony.newcombe@parexel.com.
authors.forename: Anthony R
authors.initials: AR
authors.lastname: Newcombe
mesh_terms: D001688:Biological Products; D004345:Drug Industry; D011786:Quality Control
chemical_list: D001688:Biological Products