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Biopharmaceutical manufacturing. Volume 1, Regulatory processes / Sarfaraz Niazi, Sunitha Lokesh

Author:
Niazi, Sarfaraz, 1949-
Additional Titles:
Regulatory processes
Published:
Bristol [England] (Temple Circus, Temple Way, Bristol BS1 6HG, UK) : IOP Publishing, [2021]
Physical Description:
1 online resource (various pagings) : illustrations (some color).
Additional Creators:
Lokesh, Sunitha and Institute of Physics (Great Britain)
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Series:
Contents:
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, and 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.
Summary:
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.
Subject(s):
ISBN:
9780750331753 ebook
9780750331746 mobi
9780750331739 print
9780750331760 myPrint
Audience Notes:
Industry scientists, engineers, investors, developers and other manufacturers of biopharmaceutical products.
Note:
"Version: 202112"--Title page verso.
Bibliography Note:
Includes bibliographical references.
Other Forms:
Also available in print.
Technical Details:
Mode of access: World Wide Web.
System requirements: Adobe Acrobat Reader, EPUB reader, or Kindle reader.
Administrative History:
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.
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