From laboratory to patients: dissecting obstacles in cell
BioInsights,
Looking at the cellular therapy landscape, there are more 34,000 clinical studies reported in https://clinicaltrials.gov (searchi…
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 Biologic CMC Regulation
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Altmetric BadgeChapter 2 Biologics 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 Source Materials for Biologics
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Altmetric BadgeChapter 6 Manufacture of the Biologic API
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Altmetric BadgeChapter 7 The Biologic Final Product Process
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Altmetric BadgeChapter 8 Complex Process-Related Impurities
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Altmetric BadgeChapter 9 Molecular Structural Analysis
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Altmetric BadgeChapter 10 Functional Activity (Potency)
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Altmetric BadgeChapter 11 Setting Specifications and Expiry Dates
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Altmetric BadgeChapter 12 Demonstrating Product Comparability
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Altmetric BadgeChapter 13 CMC-Focused Regulatory Meetings