000 | 05883nam a2200745 i 4500 | ||
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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 |
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020 |
_a9780750331784 _qmobi |
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020 |
_z9780750331777 _qprint |
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020 |
_z9780750331807 _qmyPrint |
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024 | 7 |
_a10.1088/978-0-7503-3179-1 _2doi |
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035 | _a(CaBNVSL)mat00083165 | ||
035 | _a(OCoLC)1303069435 | ||
040 |
_aCaBNVSL _beng _erda _cCaBNVSL _dCaBNVSL |
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050 | 4 |
_aRS380 _b.N533 2021eb vol. 2 |
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060 | 4 |
_aQV 778 _bN577b 2021eb vol. 2 |
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072 | 7 |
_aTDCW _2bicssc |
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072 | 7 |
_aTEC020000 _2bisacsh |
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082 | 0 | 4 |
_a615.19 _223 |
100 | 1 |
_aNiazi, Sarfaraz, _d1949- _eauthor. _970827 |
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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] |
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300 |
_a1 online resource (various pagings) : _billustrations (some color). |
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336 |
_atext _2rdacontent |
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337 |
_aelectronic _2isbdmedia |
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338 |
_aonline resource _2rdacarrier |
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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 |
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650 | 1 | 2 |
_aTechnology, Pharmaceutical. _98637 |
650 | 1 | 2 |
_aBiotechnology. _97533 |
650 | 7 |
_aPharmaceutical technology. _2bicssc _97812 |
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650 | 7 |
_aBiomedical engineering. _2bisacsh _93292 |
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700 | 1 |
_aLokesh, Sunitha, _eauthor. _970828 |
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710 | 2 |
_aInstitute of Physics (Great Britain), _epublisher. _911622 |
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776 | 0 | 8 |
_iPrint version: _z9780750331777 _z9780750331807 |
830 | 0 |
_aIOP (Series). _pRelease 22. _970829 |
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830 | 0 |
_aIOP ebooks. _p2022 collection. _970830 |
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856 | 4 | 0 | _uhttps://iopscience.iop.org/book/978-0-7503-3179-1 |
942 | _cEBK | ||
999 |
_c82912 _d82912 |