| 000 | 05424nam a2200721 i 4500 | ||
|---|---|---|---|
| 001 | 9780750331753 | ||
| 003 | IOP | ||
| 005 | 20230516170228.0 | ||
| 006 | m eo d | ||
| 007 | cr cn |||m|||a | ||
| 008 | 220118s2021 enka fob 000 0 eng d | ||
| 020 |
_a9780750331753 _qebook |
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| 020 |
_a9780750331746 _qmobi |
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| 020 |
_z9780750331739 _qprint |
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| 020 |
_z9780750331760 _qmyPrint |
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| 024 | 7 |
_a10.1088/978-0-7503-3175-3 _2doi |
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| 035 | _a(CaBNVSL)thg00083118 | ||
| 035 | _a(OCoLC)1291620566 | ||
| 040 |
_aCaBNVSL _beng _erda _cCaBNVSL _dCaBNVSL |
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| 050 | 4 |
_aRS380 _b.N533 2021eb vol. 1 |
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| 060 | 4 |
_aQV 778 _bN577b 2021eb vol. 1 |
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| 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] |
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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. [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 |
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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. _970327 |
|
| 710 | 2 |
_aInstitute of Physics (Great Britain), _epublisher. _911622 |
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| 776 | 0 | 8 |
_iPrint version: _z9780750331739 _z9780750331760 |
| 830 | 0 |
_aIOP (Series). _pRelease 21. _970328 |
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| 830 | 0 |
_aIOP ebooks. _p2021 collection. _970329 |
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| 856 | 4 | 0 | _uhttps://iopscience.iop.org/book/978-0-7503-3175-3 |
| 942 | _cEBK | ||
| 999 |
_c82819 _d82819 |
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