The Challenge of CMC Regulatory Compliance for Biopharmaceuticals

1. Front Matter

   Pages i-xxiii

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2. Biopharmaceutical CMC Regulatory Compliance: What is It?

   • John Geigert

   Pages 1-16

3. Are Biopharmaceuticals Really Different?

   • John Geigert

   Pages 17-34

4. Developing the Corporate CMC Regulatory Compliance Strategy

   • John Geigert

   Pages 35-55

5. Can’t Ignore cGMPs

   • John Geigert

   Pages 57-81

6. Recombinant Source Material: Master/Working Banks

   • John Geigert

   Pages 83-114

7. Production: Expansion of the Recombinant Organism and Expression of the Biopharmaceutical

   • John Geigert

   Pages 115-159

8. Purification of the Biopharmaceutical

   • John Geigert

   Pages 161-200

9. Biopharmaceutical Drug Product Manufacturing

   • John Geigert

   Pages 201-219

10. Physicochemical/Biological Analysis of the Biopharmaceutical Product

    • John Geigert

    Pages 221-285

11. Managing Process Changes — Demonstrating Product Comparability

    • John Geigert

    Pages 287-310

12. Biopharmaceutical CMC Outsourcing

    • John Geigert

    Pages 311-319

13. Concluding Thoughts on Biopharmaceutical CMC Regulatory Compliance

    • John Geigert

    Pages 321-330

14. Back Matter

    Pages 331-350

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"The greater our knowledge increases, the more our ignorance unfolds. " U. S. President John F. Kennedy, speech, Rice University, September 12, 1962 My primary purpose for writing this book was much more than to provide another information source on Chemistry, Manufacturing & Controls (CMC) that would rapidly become out of date. My primary purpose was to provide insight and practical suggestions into a common sense business approach to manage the CMC regulatory compliance requirements for biopharmaceuticals. Such a common sense business approach would need (1) to be applicable for all types of biopharmaceutical products both present and future, (2) to address the needs of a biopharmaceutical manufacturer from the beginning to the end of the clinical development stages and including post­ market approval, and (3) to be adaptable to the constantly changing CMC regulatory compliance requirements and guidance. Trying to accomplish this task was a humbling experience for this author! In Chapter 1, the CMC regulatory process is explained, the breadth of products included under the umbrella ofbiopharmaceuticals are identified, and the track record for the pharmaceutical and biopharmaceutical industry in meeting CMC regulatory compliance is discussed. In Chapter 2, while there are many CMC commonalities between biopharmaceuticals and chemically-synthesized pharmaceuticals, the significant differences in the way the regulatory agencies handle them are examined and the reasons for why such differences are necessary is discussed. Also, the importance of CMC FDA is stressed.

• DNA
• Filtration
• cell culture
• clinical trial
• development
• drug
• drug development
• drugs
• gene therapy
• manufacturing
• pharmaceutical
• protein
• research

• BioPharmaceutical Quality Solutions, Carlsbad, USA

  John Geigert

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