The Challenge of CMC Regulatory Compliance for Biopharmaceuticals

The Challenge of CMC Regulatory Compliance for Biopharmaceuticals by John Geigert.

"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...

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Bibliographic Details
Main Author: Geigert, John (Author)
Corporate Author: SpringerLink (Online service)
Format: eBook
Language:English
Published: New York, NY : Springer US : Imprint: Springer, 2004.
Edition:1st ed. 2004.
Series:Springer eBook Collection.
Subjects:
Pharmacology.
Biochemistry.
Pharmacy.
Biophysics.
Biological physics.
Electronic resources (E-books)
Online Access:Click to view e-book
Holy Cross Note:Loaded electronically.
Electronic access restricted to members of the Holy Cross Community.
Table of Contents:
  • 1 Biopharmaceutical CMC Regulatory Compliance: What is It?
  • 1. Defining Our Terms
  • 2. Under the Biopharmaceutical Umbrella
  • 3. Regulatory Development of Biopharmaceuticals
  • 4. CMC Regulatory Compliance Track Record
  • 2 Are Biopharmaceuticals Really Different?
  • 1. Perception or Reality
  • 2. Regulatory Agencies Speak
  • 3. Three Unique CMC Challenges for Biopharmaceuticals
  • 4. CMC Meetings with the FDA Take on Greater Importance
  • 5. What About CMC Meetings with Emea
  • 6. Biopharmaceuticals Need to be Treated Differently
  • 3 Developing the Corporate CMC Regulatory Compliance Strateg
  • 1. Three Key Elements for a Complete CMC Strategy
  • 2. The Minimum CMC Continuum
  • 3. Minimum CMC Requirements for Clinical Development
  • 4. Full Cmc Requirements For Dossier Filing
  • 5. ‘Case-by-Case’ CMC Strategy Specifics
  • 4 Can’t Ignore cGMP
  • 1. Not Optional
  • 2. GMPS for Everything
  • 3. Where in the Manufacturing Process Should GMP Begin
  • 4. When During Clinical Development Should GMP Begin
  • 5. Consequences of not Following GMPS
  • 6. Strategic CMC Tips for GMP Compliance
  • 5 Recombinant Source Material: Master/Working Bank
  • 1. Needed: Reliable, Continuous, Stable Genetic Source
  • 2. So Many Hosts to Choose From
  • 3. CMC Guidance on Preparation of a Bank
  • 4. CMC Guidance on Characterization of a Bank
  • 5. A Successful CMC Strategy for Banks
  • 6 Production: Expansion of the Recombinant Organism and Expression of the Biopharmaceutica
  • 1. Goals: Identity, Capacity and Consistency
  • 2. Adequate Description of the Production Process
  • 3. Validation of a Cell-Based Production Process
  • 4. Additional Production Controls and Concerns
  • 5. What Can Go Wrong
  • 6. Strategic CMC Tips For Production
  • 7 Purification of the Biopharmaceutical
  • 1. Goals: Purity, Recovery and Consistency
  • 2. Adequate Description of the Purification Process
  • 3. Facility and Utility Concerns
  • 4. Purification Process Validation
  • 5. In-Process Controls
  • 6. Process-Related Impurity Profile
  • 7. Viral Safety Evaluation
  • 8. Purification Controls for Gene Therapy Processes
  • 9. What Can Go Wrong
  • 8 Biopharmaceutical Drug Product Manufacturing
  • 1. Three Basic CMC Regulatory Concerns
  • 2. Formulation of a Biopharmaceutical
  • 3. Biopharmaceutial Manufacturing Processes
  • 4. Adequate Description of the Manufacturing Process
  • 5. Adequate Control Over the Manufacturing Process
  • 6. What Can Go Wrong
  • 7. Strategic CMC Tips for Drug Product Manufacturing
  • 9 Physicochemical/Biological Analysis of the Biopharmaceutical Produc
  • 1. A Challenging Analysis
  • 2. Unraveling the Molecular Properties
  • 3. Characterization of Biopharmaceuticals
  • 4. Release Testing and Specifications
  • 5. Biopharmaceutical Stability and Expiration Dating
  • 6. What Can Go Wrong
  • 7. Strategic Cmc Tips For Biopharmaceutical Analysis
  • 10 Managing Process Changes — Demonstrating Product Comparabilit
  • 1. Not As Easy as it Seems
  • 2. Regulatory Management of Process Changes
  • 3. Demonstrating Product Comparability
  • 4. Comparability Protocols
  • 5. Case Examples of Biopharmaceutical Comparability
  • 11 Biopharmaceutical CMC Outsourcing
  • 1. Regulatory Expectations for Contracted Works
  • 2. Developing the Intercompany Quality Agreement
  • 3. Strategic CMC Tips for Outsourcing
  • 12 Concluding Thoughts on Biopharmaceutical CMC Regulatory Compliance
  • 1. Most Helpful Websites for Biopharmaceuticals
  • 2. Website Resources from FDA
  • 3. Resources from Emea
  • 4. Resources from Professional Associations
  • 5. Conclusion
  • References.

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