Strategies for Successful Scale-up Using Quality by Design

Successful scale-up from clinical-scale to commercial-scale production is imperative for realizing the market opportunities for a drug product. As pharmaceutical companies adopt Quality by Design (QbD), scalability is even more challenging and complex. Realizing the benefits of QbD requires setting a foundation in development by identifying critical quality attributes (CQA) and critical process parameters (CPPs) and understanding how those CQAs and CPPs may need to be redefined with scale-up and related modifications in equipment, material attributes or process changes.

The downloadable slide decks below will outline best practices for ensuring successful scale-up for manufacturing finished drug products by offering a systematic approach and technical case studies for implementing QbD through development to scale-up and commercial manufacture.

Key Learning Objectives

  • Understand how equipment, material attributes or process changes influence critical quality attributes and critical process parameters in scaling up finished-drug manufacturing
  • Learn how to best develop a scale-up risk assessment
  • Evaluate the robustness of a manufacturing process using QbD


Rita Peters
Editorial Director
Pharmaceutical Technology


Chris Potter, CMC
Pharmaceutical Consultant,
PQLI Technical Project Manager, ISPE

Michael Lowenborg
R&D Manager for Formulation
& Process Development, DPT Laboratories


Download Chris Potter’s Slides

Download Michael Lowenborg’s Slides