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 …

The concepts, applications, and practical issues of Quality by Design Quality by Design
(QbD) is a new framework currently being implemented by the FDA, as well as EU and …

The foundation for success of Quality by Design (QbD) for biologics is in place. QbD
practices have already added significant value to developing biologic processes and to a …

Enhanced process and product understanding are the basic tenets of Quality by Design
(QbD). A QbD approach for setting specifications would involve harnessing this …

The pharmaceutical industry works hard to develop, manufacture, and bring to market new
drugs—and to comply with regulatory requirements to demonstrate that the drugs are safe …

Quality by design (QbD) is a science‐and risk‐based approach to drug product
development. Although pharmaceutical companies have historically used many of the same …

BioProcess International 85 SUPPLEMENT hand the full-scale process over to the
production facility. Often, there is inefficient interaction between the personnel that develop …

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) …

This article reviews the history of quality-by-design (QbD), how this concept has been
applied to biopharmaceuticals, and what can be expected from implementation of QbD …

This chapter contains sections titled: Introduction Quality by Design Relevant Product
Attributes Manufacturing Process Developing a Design Space Uncertainty and Complexity …