The Evolution of quality by design (QbD) for biologics

PDA J Pharm Sci Technol. 2014 Jul-Aug;68(4):320-2. doi: 10.5731/pdajpst.2014.00989.


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.

MeSH terms

  • Biological Products*
  • Drug Industry
  • Quality Control*


  • Biological Products