Book description
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.
Anurag S. Rathore received his PhD in chemical
engineering from Yale University and is the Director of Process
Development, Amgen Inc. His areas of interest include process
development, scale-up, technology transfer, process validation,
process analytical technology, and quality by design. He has authored
more than 100 publications and presentations in these areas and serves
on the editorial advisory boards for Biotechnology Progress,
BioPharm International, Pharmaceutical Technology Europe, Journal of
Biochemical and Biophysical Methods, and Separation and Purification Reviews.
Rohin Mhatre is a Senior Director in the BioProcess Development
department at Biogen Idec, Cambridge, Massachusetts, and has been with
the company since 1996. His group is responsible for development of
analytical methods and product characterization to support the process
and formulation development of early and late stage clinical programs.
Mhatre is also leading the QbD initiative within Biogen Idec. He has
authored several publications and been an invited speaker to numerous
scientific meetings.
