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Quality by Design for Biopharmaceuticals
eBook Publisher: John Wiley & Sons
Imprint: Wiley-Interscience
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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.
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| Title of eBook: Quality by Design for Biopharmaceuticals | |
| Release Date: 09-20-2011 | |
| Publisher: Wiley-Interscience |
This eBook download is available in the following formats:
| Parent title | Quality by Design for... |
|---|---|
| Encrypted (DRM) | Yes |
| SKU | 9780470466308 |
| File size | 15313 |
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Quality by Design for Biopharmaceuticals
Chapter One
QUALITY BY DESIGN: AN OVERVIEW OF THE BASIC CONCEPTSRohin 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. 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. 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. 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-p
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