Biomedical Engineering Reference
In-Depth Information
1
QUALITY BY DESIGN: AN
OVERVIEW OF THE BASIC
CONCEPTS
Rohin Mhatre and Anurag S. Rathore
1.1 INTRODUCTION
The premise of Quality by Design (QbD) is that the quality of the pharmaceutical product
should be based upon the understanding of the biology or the mechanism of action
(MOA) and the safety of the molecule [1]. The manufacturing process should then be
developed to meet the desired quality attributes of the molecule, hence the concept of
“design” of the product quality versus “testing” the product quality. Although testing the
product quality after manufacturing is an essential element of quality control, testing
should be conducted to confirm the predesired product attributes and not to simply reveal
the outcome of a manufacturing process. The ICH Q8 guideline provides an overview of
some of the aspects of QbD [2]. The guideline clearly states that quality cannot be tested
into products; that is, quality should be built in by design.
Although the task of designing a complex biological molecule such as a monoclonal
antibody may seem daunting, the experience gained in the past roughly 30 years of the
biotechnology industry history has laid the foundation for the QbD initiative [3, 4]. The
industry has come a long way in identifying and selecting viable drug candidates, in
developing high-productivity cell culture processes, in designing purification processes
that yield a high-purity product, and in analyzing the heterogeneity of complex
