Rathore / Mhatre Quality by Design for Biopharmaceuticals

Principles and Case Studies
1. Auflage 2009
ISBN: 978-0-470-46630-8
Verlag: John Wiley & Sons
Format: PDF
Kopierschutz: Adobe DRM (»Systemvoraussetzungen)

E-Book, Englisch, 312 Seiten, E-Book

Reihe: Wiley Series on Biotechnology

The concepts, applications, and practical issues of Quality byDesign
Quality by Design (QbD) is a new framework currently beingimplemented by the FDA, as well as EU and Japanese regulatoryagencies, to ensure better understanding of the process so as toyield a consistent and high-quality pharmaceutical product. QbDbreaks from past approaches in assuming that drug quality cannot betested into products; rather, it must be built into every step ofthe product creation process.
Quality by Design: Perspectives and Case Studies presentsthe first systematic approach to QbD in the biotech industry. Acomprehensive resource, it combines an in-depth explanation ofbasic concepts with real-life case studies that illustrate thepractical aspects of QbD implementation.
In this single source, leading authorities from thebiotechnology industry and the FDA discuss such topics as:
* The understanding and development of the product's criticalquality attributes (CQA)
* Development of the design space for a manufacturingprocess
* 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 toQbD
* Relevant PAT tools and applications for the pharmaceuticalindustry
* The uses of risk assessment and management in QbD
* Filing QbD information in regulatory documents
* The application of multivariate data analysis (MVDA) toQbD
Filled with vivid case studies that illustrate QbD at work incompanies today, Quality by Design is a core reference forscientists in the biopharmaceutical industry, regulatory agencies,and students.

Autoren/Hrsg.

Rathore, Anurag S.

Mhatre, Rohin

Inhaltsverzeichnis

Preface.
1. Quality by Design (QbD): An Overview of the Basic Concepts (Rohin Mhatre and Anurag S. Rathore).
2. Considerations for Biotechnology Product Quality by Design (Steven Kozlowski and Patrick Swann).
3. Molecular Design of Recombinant Malaria Vaccines Expressed (Pichia Pastoris).
4. Using a Risk Assessment Process to Determine Criticality of Product Quality Attributes (Mark A Schenerman, Milton J Axley, Cynthia N Oliver, Kripa Ram, and Gail F Wasserman).
5. Case Study on Definition of Process Design Space for a Microbial Fermentation Step (Pim van Hoek, Jean Harms, Xiangyang Wang, and Anurag S. Rathore).
6. Applications of Design Space for Biopharmaceutical Purification Processes (Douglas J. Cecchini).
7. Viral Clearance: A Strategy for Quality by Design and the Design Space (Gail Sofer and Jeffrey Carter).
8. Application of Quality by Design and Risk Assessment Principles for the Development of Formulation Design Space (Kingman Ng and Natarajan Rajagopalan).
9. QbD for Raw Materials (Anurag S. Rathore).
10. PAT Tools for Biologics: Considerations and Challenges (Michael Molony and Cenk Undey).
11. Evolution and Integration of Quality by Design and Process Analytical Technology (Duncan Low and Joseph Phillips).

Über Autor(innen)

Anurag S. Rathore received his PhD in chemical engineeringfrom Yale University and is the Director of Process Development,Amgen Inc. His areas of interest include process development,scale-up, technology transfer, process validation, processanalytical technology, and quality by design. He has authored morethan 100 publications and presentations in these areas and serveson the editorial advisory boards for Biotechnology Progress,BioPharm International, Pharmaceutical Technology Europe, Journalof Biochemical and Biophysical Methods, and Separation andPurification Reviews.
Rohin Mhatre is a Senior Director in the BioProcessDevelopment department at Biogen Idec, Cambridge, Massachusetts,and has been with the company since 1996. His group is responsiblefor development of analytical methods and product characterizationto support the process and formulation development of early andlate stage clinical programs. Mhatre is also leading the QbDinitiative within Biogen Idec. He has authored several publicationsand been an invited speaker to numerous scientific meetings.