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The Challenge of CMC Regulatory Compliance for Biopharmaceuticals
Overview of attention for book
Table of Contents
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Altmetric BadgeBook Overview
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Altmetric BadgeChapter 1 Complexity of Biologics CMC Regulation
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Altmetric BadgeChapter 2 Biopharmaceuticals Are Not Chemical Drugs
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Altmetric BadgeChapter 3 An Effective CMC Strategy is Possible
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Altmetric BadgeChapter 4 Challenge of Adventitious Agent Control
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Altmetric BadgeChapter 5 Biopharmaceutical Source Materials
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Altmetric BadgeChapter 6 Manufacturing of Biopharmaceutical APIs
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Altmetric BadgeChapter 7 Manufacturing of the Drug Product
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Altmetric BadgeChapter 8 Complex Process-Related Impurity Profiles
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Altmetric BadgeChapter 9 Product Characterization is a Journey
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Altmetric BadgeChapter 10 Priceless Potency (Therapeutic Activity)
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Altmetric BadgeChapter 11 Quality Attributes of a Biopharmaceutical
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Altmetric BadgeChapter 12 Designing the Stability Program
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Altmetric BadgeChapter 13 The Art of Setting Specifications
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Altmetric BadgeChapter 14 Demonstrating Product Comparability After Process Changes
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Altmetric BadgeChapter 15 Invaluable CMC-Focused Meetings with Regulatory Authorities