Wiley.com
Print this page Share

Quality by Design for Biopharmaceuticals: Principles and Case Studies

Anurag S. Rathore (Editor), Rohin Mhatre (Editor)
ISBN: 978-0-470-28233-5
Hardcover
328 pages
June 2009
List Price: US $155.00
Government Price: US $106.84
Enter Quantity:   Buy
Quality by Design for Biopharmaceuticals: Principles and Case Studies  (0470282339) cover image
This is a Print-on-Demand title. It will be printed specifically to fill your order. Please allow an additional 10-15 days delivery time. The book is not returnable.

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 Japanese regulatory agencies, to ensure better understanding of the process so as to yield a consistent and high-quality pharmaceutical product. QbD breaks from past approaches in assuming that drug quality cannot be tested into products; rather, it must be built into every step of the product creation process.

Quality by Design: Perspectives and Case Studies presents the first systematic approach to QbD in the biotech industry. A comprehensive resource, it combines an in-depth explanation of basic concepts with real-life case studies that illustrate the practical aspects of QbD implementation.

In this single source, leading authorities from the biotechnology industry and the FDA discuss such topics as:

  • The understanding and development of the product's critical quality attributes (CQA)
  • Development of the design space for a manufacturing process
  • How to employ QbD to design a formulation process
  • Raw material analysis and control strategy for QbD
  • Process Analytical Technology (PAT) and how it relates to QbD
  • Relevant PAT tools and applications for the pharmaceutical industry
  • The uses of risk assessment and management in QbD
  • Filing QbD information in regulatory documents
  • The application of multivariate data analysis (MVDA) to QbD

Filled with vivid case studies that illustrate QbD at work in companies today, Quality by Design is a core reference for scientists in the biopharmaceutical industry, regulatory agencies, and students.

Related Titles

More From This Series

by Arsenio Fialho (Editor), Ananda Chakrabarty (Editor)

Biotechnology

by Wu-Kuang Yeh (Editor), Hsiu-Chiung Yang (Editor), James R. McCarthy (Editor)
by Hiroshi Ashihara (Editor), Alan Crozier (Co-Editor), Atsushi Komamine (Co-Editor)
Back to Top