TY - JOUR T1 - The Evolution of Quality by Design (QbD) for Biologics JF - PDA Journal of Pharmaceutical Science and Technology JO - PDA J Pharm Sci Technol SP - 320 LP - 322 DO - 10.5731/pdajpst.2014.00989 VL - 68 IS - 4 AU - Anthony R. Newcombe Y1 - 2014/07/01 UR - http://journal.pda.org/content/68/4/320.abstract N2 - LAY 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. ER -