000 05883nam a2200745 i 4500
001 9780750331791
003 IOP
005 20230516170312.0
006 m eo d
007 cr cn |||m|||a
008 220301s2022 enka fob 000 0 eng d
020 _a9780750331791
_qebook
020 _a9780750331784
_qmobi
020 _z9780750331777
_qprint
020 _z9780750331807
_qmyPrint
024 7 _a10.1088/978-0-7503-3179-1
_2doi
035 _a(CaBNVSL)mat00083165
035 _a(OCoLC)1303069435
040 _aCaBNVSL
_beng
_erda
_cCaBNVSL
_dCaBNVSL
050 4 _aRS380
_b.N533 2021eb vol. 2
060 4 _aQV 778
_bN577b 2021eb vol. 2
072 7 _aTDCW
_2bicssc
072 7 _aTEC020000
_2bisacsh
082 0 4 _a615.19
_223
100 1 _aNiazi, Sarfaraz,
_d1949-
_eauthor.
_970827
245 1 0 _aBiopharmaceutical manufacturing.
_nVolume 2,
_pUnit processes /
_cSarfaraz Niazi, Sunitha Lokesh.
264 1 _aBristol [England] (Temple Circus, Temple Way, Bristol BS1 6HG, UK) :
_bIOP Publishing,
_c[2022]
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. [2022 collection]
500 _a"Version: 202201"--Title page verso.
504 _aIncludes bibliographical references.
505 0 _a1. Understanding bioprocessing -- 1.1. Overview -- 1.2. Key considerations for the production of biotherapeutics -- 1.3. Chromatography methods -- 1.4. Process lifecycle -- 1.5. Costing -- 1.6. Facility design -- 1.7. Testing -- 1.8. Documentation process -- 1.9. Conclusion
505 8 _a2. Recombinant manufacturing system -- 2.1. Overview -- 2.2. Recombinant DNA -- 2.3. Expression systems -- 2.4. Conclusion
505 8 _a3. Cell line development -- 3.1. Overview -- 3.2. Overview of protein expression -- 3.3. Host cell engineering -- 3.4. Conclusion -- 3.5. Appendix
505 8 _a4. Upstream equipment and systems -- 4.1. Overview -- 4.2. Medium and solution preparation systems -- 4.3. Bioreactor systems -- 4.4. Harvest and clarification systems -- 4.5. Ancillary and peripheral equipment -- 4.6. Conclusion
505 8 _a5. Upstream processing -- 5.1. Overview -- 5.2. Culture media -- 5.3. Cell culture fermentation -- 5.4. Conclusion
505 8 _a6. Downstream process -- 6.1. Overview -- 6.2. E. coli system : recovery and purification -- 6.3. Mammalian system purification -- 6.4. Product concentration -- 6.5. Analytical methods -- 6.6. Downstream processing equipment and system components -- 6.7. Conclusion
505 8 _a7. Process and product lifecycle development -- 7.1. Overview -- 7.2. Process development -- 7.3. Process scale-up -- 7.4. Technology transfer -- 7.5. Process characterization and optimization -- 7.6. Process validation -- 7.7. Process control strategy -- 7.8. Testing methods -- 7.9. Conclusion
505 8 _a8. Quality and compliance systems -- 8.1. Overview -- 8.2. Quality system -- 8.3. Validation master plan -- 8.4. Good laboratory practices -- 8.5. Quality control -- 8.6. Regulatory compliance -- 8.7. Conclusion
505 8 _a9. Single-use technology -- 9.1. Overview -- 9.2. Single-use containers and mixing systems -- 9.3. Upstream processing -- 9.4. Connectors and transfer systems -- 9.5. Sampling -- 9.6. Downstream processing -- 9.7. Safety -- 9.8. Regulatory matters -- 9.9. Advantages -- 9.10. Conclusion
505 8 _a10. Advancements and trends in biomanufacturing -- 10.1. Overview -- 10.2. Cell line development -- 10.3. Upstream process intensification -- 10.4. Downstream -- 10.5. Continuous manufacturing -- 10.6. Process analytical technology (PAT) -- 10.7. Automation -- 10.8. 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. This volume covers the unit processes involved in producing a GMP (Good Manufacturing Practice) biopharmaceutical product, laid out in the order of operation, with complete details on equipment, compliance and yield improvement suggestions.
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 March 8, 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.
_970828
710 2 _aInstitute of Physics (Great Britain),
_epublisher.
_911622
776 0 8 _iPrint version:
_z9780750331777
_z9780750331807
830 0 _aIOP (Series).
_pRelease 22.
_970829
830 0 _aIOP ebooks.
_p2022 collection.
_970830
856 4 0 _uhttps://iopscience.iop.org/book/978-0-7503-3179-1
942 _cEBK
999 _c82912
_d82912