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The Challenge of CMC Regulatory Compliance for Biopharmaceuticals

Overview of attention for book
Cover of 'The Challenge of CMC Regulatory Compliance for Biopharmaceuticals'

Table of Contents

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    Book Overview
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    Chapter 1 Complexity of Biologic CMC Regulation
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    Chapter 2 Biologics Are Not Chemical Drugs
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    Chapter 3 An Effective CMC Strategy is Possible
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    Chapter 4 Challenge of Adventitious Agent Control
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    Chapter 5 Source Materials for Biologics
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    Chapter 6 Manufacture of the Biologic API
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    Chapter 7 The Biologic Final Product Process
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    Chapter 8 Complex Process-Related Impurities
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    Chapter 9 Molecular Structural Analysis
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    Chapter 10 Functional Activity (Potency)
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    Chapter 11 Setting Specifications and Expiry Dates
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    Chapter 12 Demonstrating Product Comparability
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    Chapter 13 CMC-Focused Regulatory Meetings
Attention for Chapter 6: Manufacture of the Biologic API
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