Biopharmaceutical manufacturing. Volume 1, Regulatory processes /

This two-volume set provides a comprehensive guide to the essential aspects of commercial biopharmaceutical manufacturing. Covering the planning, layout and operation of successful commercial manufacturing, the aim of the books is to enable innovations, new drug development, and make affordable biol...

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Detalles Bibliográficos
Clasificación:Libro Electrónico
Autores principales: Niazi, Sarfaraz, 1949- (Autor), Lokesh, Sunitha (Autor)
Formato: Electrónico eBook
Idioma:Inglés
Publicado: Bristol [England] (Temple Circus, Temple Way, Bristol BS1 6HG, UK) : IOP Publishing, [2021]
Colección:IOP (Series). Release 21.
IOP ebooks. 2021 collection.
Temas:
Pharmaceutical biotechnology.
Technology, Pharmaceutical.
Biotechnology.
Pharmaceutical technology.
Biomedical engineering.
Acceso en línea:Texto completo
Tabla de Contenidos:
  • 1. Introduction to biopharmaceuticals
  • 1.1. Overview
  • 1.2. Biopharmaceutical molecules
  • 1.3. Protein structure and properties
  • 1.4. Pharmacokinetic manipulations
  • 1.5. Immunogenicity
  • 1.6. Recombinant expression
  • 1.7. Gene and cell therapy
  • 1.8. Conclusion
  • 2. Antibody biopharmaceuticals
  • 2.1. Overview
  • 2.2. The immune system
  • 2.3. Monoclonal antibodies
  • 2.4. Types of antibodies
  • 2.5. Development of antibodies
  • 2.6. Conclusion
  • 2.7. Databases relevant to antibodies
  • 3. Gene and cell therapy
  • 3.1. Overview
  • 3.2. Gene therapy
  • 3.3. Cell therapy
  • 3.4. Regulatory considerations
  • 3.5. Conclusion
  • 4. Formulation of biopharmaceuticals
  • 4.1. Overview
  • 4.2. Structural instability
  • 4.3. Formulation composition
  • 4.4. Delivery routes
  • 4.5. Formulation technologies
  • 4.6. Examples of formulation
  • 5. Biopharmaceutical development cycle
  • 5.1. Overview
  • 5.2. The US drug development process
  • 5.3. Drug development in Europe
  • 5.4. Japanese drug approval process
  • 5.5. Conclusion
  • 6. Biosimilar biopharmaceuticals
  • 6.1. Overview
  • 6.2. Biosimilarity
  • 6.3. Regulatory guidance
  • 6.4. Development master plan
  • 6.5. Interchangeability and substitution
  • 6.6. Analytical assessment
  • 6.7. Functional assessment
  • 6.8. In vivo assessment
  • 6.9. Clinical pharmacology assessment
  • 6.10. Clinical immunogenicity assessment
  • 6.11. Clinical efficacy assessment
  • 6.12. Extrapolation of clinical data across indications
  • 6.13. Conclusion
  • 7. Intellectual property issues for scientists
  • 7.1. Overview
  • 7.2. Patent law basics
  • 7.3. US patent elements
  • 7.4. Types of patents
  • 7.5. Comparison of patent laws
  • 7.6. Biological patents
  • 7.7. Monoclonal antibody technology
  • 7.8. Antisense technology
  • 7.9. Transgenic plants
  • 7.10. Exclusivities for biological products
  • 7.11. Broad coverage
  • 7.12. The Purple Book
  • 7.13. Patent term extension
  • 7.14. Patent term adjustment
  • 7.15. Freedom-to-operate (FTO) opinions
  • 7.16. Conclusion.

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