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

MARC

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082 0 4 |a 615.19  |2 23 
100 1 |a Niazi, Sarfaraz,  |d 1949-  |e author. 
245 1 0 |a Biopharmaceutical manufacturing.  |n Volume 1,  |p Regulatory processes /  |c Sarfaraz Niazi, Sunitha Lokesh. 
246 3 0 |a Regulatory processes. 
264 1 |a Bristol [England] (Temple Circus, Temple Way, Bristol BS1 6HG, UK) :  |b IOP Publishing,  |c [2021] 
300 |a 1 online resource (various pagings) :  |b illustrations (some color). 
336 |a text  |2 rdacontent 
337 |a electronic  |2 isbdmedia 
338 |a online resource  |2 rdacarrier 
490 1 |a [IOP release $release] 
490 1 |a IOP ebooks. [2021 collection] 
500 |a "Version: 202112"--Title page verso. 
504 |a Includes bibliographical references. 
505 0 |a 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 
505 8 |a 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 
505 8 |a 3. Gene and cell therapy -- 3.1. Overview -- 3.2. Gene therapy -- 3.3. Cell therapy -- 3.4. Regulatory considerations -- 3.5. Conclusion 
505 8 |a 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 
505 8 |a 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 
505 8 |a 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 
505 8 |a 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. 
520 3 |a 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 biological drugs available to patients worldwide. 
521 |a Industry scientists, engineers, investors, developers and other manufacturers of biopharmaceutical products. 
530 |a Also available in print. 
538 |a Mode of access: World Wide Web. 
538 |a System requirements: Adobe Acrobat Reader, EPUB reader, or Kindle reader. 
545 |a Sarfaraz K Niazi is an adjunct professor at the University of Illinois and University of Houston. Prof. Niazi has established numerous consulting businesses and start-up companies within the biopharmaceutical industry, including Pharmaceutical Scientist, Inc and Karyo Biologics, LLC. Sunitha Lokesh is the director of biomanufacturing operations at Pharmaceutical Scientist Inc., where she leads the identification and technology development of biopharmaceutical products. 
588 0 |a Title from PDF title page (viewed on January 18, 2022). 
650 0 |a Pharmaceutical biotechnology. 
650 1 2 |a Technology, Pharmaceutical. 
650 1 2 |a Biotechnology. 
650 7 |a Pharmaceutical technology.  |2 bicssc 
650 7 |a Biomedical engineering.  |2 bisacsh 
700 1 |a Lokesh, Sunitha,  |e author. 
710 2 |a Institute of Physics (Great Britain),  |e publisher. 
776 0 8 |i Print version:  |z 9780750331739  |z 9780750331760 
830 0 |a IOP (Series).  |p Release 21. 
830 0 |a IOP ebooks.  |p 2021 collection. 
856 4 0 |u https://iopscience.uam.elogim.com/book/978-0-7503-3175-3  |z Texto completo 

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