Provides an update on the status of biosimilars and a perspective for the next decade. How biosimilars are developed in the future will include many AI-based features to establish structural similarity that will prevent the need for most other testing, including detailed analytical assessment and clinical pharmacology testing.
Provides an update on the status of biosimilars and a perspective for the next decade. How biosimilars are developed in the future will include many AI-based features to establish structural similarity that will prevent the need for most other testing, including detailed analytical assessment and clinical pharmacology testing.
Sarfaraz K Niazi, Ph.D., is an Adjunct Professor at the University of Illinois. He has authored 60+ major books, 100+ research papers, and 100+ patents, mainly in bioprocessing. He has hands-on experience establishing biopharmaceutical projects, from concept to market, including setting up the first biosimilar company in the US and leading to several FDA approvals. He serves as an advisor to several regulatory agencies, including the FDA.
Inhaltsangabe
Preface Chapter 1 All About Biosimilars 1. Introduction 2. Approvals 3. Future Candidates 4. Approval Guidelines 5. Waivers 6. Appendix: Terminology 7. Appendix 2: Therapeutic Proteins approved by the FDA: potential biosimilar candidates. 8. Bibliography Chapter 2 Product Type and Selection Strategies 1. Background 2. Exclusivity 3. Formulation 4. Route of Administration 5. Reference Product Chapter 3 Development Master Plan 1. Introduction 2. Creating a Plan 3. Intellectual Property 4. Expression System 5. Release Specification 6. Nonclinical Testing 7. Clinical Pharmacology Assessment 8. Clinical Immunogenicity Assessment 9. Clinical Efficacy Assessment 10. Extrapolation of Clinical Data Across Indications 11. Interchangeability and Substitution Chapter 4 Optimization of Cost of Goods 1. Background 2. Creation of Cell Lines 3. Media 4. Containers and Mixing Systems 5. Working downstream 6. Regulatory 7. Ongoing Production 8. Continuous Manufacturing Chapter 5 Strategic Understanding for Biosimilars Future 1. Introduction 2. The Role of the US Congress 3. The Role of the FDA 4. The Role of Developers 5. The Role of the Associations 6. Conclusions Chapter 6 Repurposing Biosimilars 1. Introduction 2. Understanding Therapeutic Proteins 3. Reinvention Scope 4. Intellectual Property 5. Artificial Intelligence (AI) and Machine Learning (ML) 6. Structure Prediction 7. Target identification 8. Molecular Docking 9. Drug Conjugates 10. Regulatory Perspective 11. Conclusions 12. References
Preface Chapter 1 All About Biosimilars 1. Introduction 2. Approvals 3. Future Candidates 4. Approval Guidelines 5. Waivers 6. Appendix: Terminology 7. Appendix 2: Therapeutic Proteins approved by the FDA: potential biosimilar candidates. 8. Bibliography Chapter 2 Product Type and Selection Strategies 1. Background 2. Exclusivity 3. Formulation 4. Route of Administration 5. Reference Product Chapter 3 Development Master Plan 1. Introduction 2. Creating a Plan 3. Intellectual Property 4. Expression System 5. Release Specification 6. Nonclinical Testing 7. Clinical Pharmacology Assessment 8. Clinical Immunogenicity Assessment 9. Clinical Efficacy Assessment 10. Extrapolation of Clinical Data Across Indications 11. Interchangeability and Substitution Chapter 4 Optimization of Cost of Goods 1. Background 2. Creation of Cell Lines 3. Media 4. Containers and Mixing Systems 5. Working downstream 6. Regulatory 7. Ongoing Production 8. Continuous Manufacturing Chapter 5 Strategic Understanding for Biosimilars Future 1. Introduction 2. The Role of the US Congress 3. The Role of the FDA 4. The Role of Developers 5. The Role of the Associations 6. Conclusions Chapter 6 Repurposing Biosimilars 1. Introduction 2. Understanding Therapeutic Proteins 3. Reinvention Scope 4. Intellectual Property 5. Artificial Intelligence (AI) and Machine Learning (ML) 6. Structure Prediction 7. Target identification 8. Molecular Docking 9. Drug Conjugates 10. Regulatory Perspective 11. Conclusions 12. References
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