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The Challenge of CMC Regulatory Compliance for Biopharmaceuticals

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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 Biologics CMC Regulation
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    Chapter 2 Biopharmaceuticals 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 Biopharmaceutical Source Materials
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    Chapter 6 Manufacturing of Biopharmaceutical APIs
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    Chapter 7 Manufacturing of the Drug Product
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    Chapter 8 Complex Process-Related Impurity Profiles
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    Chapter 9 Product Characterization is a Journey
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    Chapter 10 Priceless Potency (Therapeutic Activity)
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    Chapter 11 Quality Attributes of a Biopharmaceutical
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    Chapter 12 Designing the Stability Program
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    Chapter 13 The Art of Setting Specifications
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    Chapter 14 Demonstrating Product Comparability After Process Changes
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    Chapter 15 Invaluable CMC-Focused Meetings with Regulatory Authorities
Attention for Chapter 1: Complexity of Biologics CMC Regulation
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