000 05424nam a2200721 i 4500
001 9780750331753
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006 m eo d
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008 220118s2021 enka fob 000 0 eng d
020 _a9780750331753
_qebook
020 _a9780750331746
_qmobi
020 _z9780750331739
_qprint
020 _z9780750331760
_qmyPrint
024 7 _a10.1088/978-0-7503-3175-3
_2doi
035 _a(CaBNVSL)thg00083118
035 _a(OCoLC)1291620566
040 _aCaBNVSL
_beng
_erda
_cCaBNVSL
_dCaBNVSL
050 4 _aRS380
_b.N533 2021eb vol. 1
060 4 _aQV 778
_bN577b 2021eb vol. 1
072 7 _aTDCW
_2bicssc
072 7 _aTEC020000
_2bisacsh
082 0 4 _a615.19
_223
100 1 _aNiazi, Sarfaraz,
_d1949-
_eauthor.
_970326
245 1 0 _aBiopharmaceutical manufacturing.
_nVolume 1,
_pRegulatory processes /
_cSarfaraz Niazi, Sunitha Lokesh.
246 3 0 _aRegulatory processes.
264 1 _aBristol [England] (Temple Circus, Temple Way, Bristol BS1 6HG, UK) :
_bIOP Publishing,
_c[2021]
300 _a1 online resource (various pagings) :
_billustrations (some color).
336 _atext
_2rdacontent
337 _aelectronic
_2isbdmedia
338 _aonline resource
_2rdacarrier
490 1 _a[IOP release $release]
490 1 _aIOP ebooks. [2021 collection]
500 _a"Version: 202112"--Title page verso.
504 _aIncludes bibliographical references.
505 0 _a1. 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 _a2. 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 _a3. Gene and cell therapy -- 3.1. Overview -- 3.2. Gene therapy -- 3.3. Cell therapy -- 3.4. Regulatory considerations -- 3.5. Conclusion
505 8 _a4. 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 _a5. 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 _a6. 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 _a7. 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 _aThis 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 _aIndustry scientists, engineers, investors, developers and other manufacturers of biopharmaceutical products.
530 _aAlso available in print.
538 _aMode of access: World Wide Web.
538 _aSystem requirements: Adobe Acrobat Reader, EPUB reader, or Kindle reader.
545 _aSarfaraz 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 _aTitle from PDF title page (viewed on January 18, 2022).
650 0 _aPharmaceutical biotechnology.
_914618
650 1 2 _aTechnology, Pharmaceutical.
_98637
650 1 2 _aBiotechnology.
_97533
650 7 _aPharmaceutical technology.
_2bicssc
_97812
650 7 _aBiomedical engineering.
_2bisacsh
_93292
700 1 _aLokesh, Sunitha,
_eauthor.
_970327
710 2 _aInstitute of Physics (Great Britain),
_epublisher.
_911622
776 0 8 _iPrint version:
_z9780750331739
_z9780750331760
830 0 _aIOP (Series).
_pRelease 21.
_970328
830 0 _aIOP ebooks.
_p2021 collection.
_970329
856 4 0 _uhttps://iopscience.iop.org/book/978-0-7503-3175-3
942 _cEBK
999 _c82819
_d82819