↓ Skip to main content
What is this page? Embed badge

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

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

Citations

dimensions_citation
15 Dimensions
Summary Dimensions citations
So far, Dimensions has found 15 publications that cite this research output.

15

The most recent citing publications are shown below. View all 15 publications that cite this research output on Dimensions.

This page shows the most recent citations of this research output.

Click here to find out how to access more activity.

This page is provided by Altmetric.