Biopharmaceutical manufacturing. (Record no. 82819)
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| 000 -LEADER | |
|---|---|
| fixed length control field | 05424nam a2200721 i 4500 |
| 001 - CONTROL NUMBER | |
| control field | 9780750331753 |
| 003 - CONTROL NUMBER IDENTIFIER | |
| control field | IOP |
| 005 - DATE AND TIME OF LATEST TRANSACTION | |
| control field | 20230516170228.0 |
| 006 - FIXED-LENGTH DATA ELEMENTS--ADDITIONAL MATERIAL CHARACTERISTICS | |
| fixed length control field | m eo d |
| 007 - PHYSICAL DESCRIPTION FIXED FIELD--GENERAL INFORMATION | |
| fixed length control field | cr cn |||m|||a |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION | |
| fixed length control field | 220118s2021 enka fob 000 0 eng d |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER | |
| International Standard Book Number | 9780750331753 |
| Qualifying information | ebook |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER | |
| International Standard Book Number | 9780750331746 |
| Qualifying information | mobi |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER | |
| Canceled/invalid ISBN | 9780750331739 |
| Qualifying information | |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER | |
| Canceled/invalid ISBN | 9780750331760 |
| Qualifying information | myPrint |
| 024 7# - OTHER STANDARD IDENTIFIER | |
| Standard number or code | 10.1088/978-0-7503-3175-3 |
| Source of number or code | doi |
| 035 ## - SYSTEM CONTROL NUMBER | |
| System control number | (CaBNVSL)thg00083118 |
| 035 ## - SYSTEM CONTROL NUMBER | |
| System control number | (OCoLC)1291620566 |
| 040 ## - CATALOGING SOURCE | |
| Original cataloging agency | CaBNVSL |
| Language of cataloging | eng |
| Description conventions | rda |
| Transcribing agency | CaBNVSL |
| Modifying agency | CaBNVSL |
| 050 #4 - LIBRARY OF CONGRESS CALL NUMBER | |
| Classification number | RS380 |
| Item number | .N533 2021eb vol. 1 |
| 060 #4 - NATIONAL LIBRARY OF MEDICINE CALL NUMBER | |
| Classification number | QV 778 |
| Item number | N577b 2021eb vol. 1 |
| 072 #7 - SUBJECT CATEGORY CODE | |
| Subject category code | TDCW |
| Source | bicssc |
| 072 #7 - SUBJECT CATEGORY CODE | |
| Subject category code | TEC020000 |
| Source | bisacsh |
| 082 04 - DEWEY DECIMAL CLASSIFICATION NUMBER | |
| Classification number | 615.19 |
| Edition number | 23 |
| 100 1# - MAIN ENTRY--PERSONAL NAME | |
| Personal name | Niazi, Sarfaraz, |
| Dates associated with a name | 1949- |
| Relator term | author. |
| 9 (RLIN) | 70326 |
| 245 10 - TITLE STATEMENT | |
| Title | Biopharmaceutical manufacturing. |
| Number of part/section of a work | Volume 1, |
| Name of part/section of a work | Regulatory processes / |
| Statement of responsibility, etc. | Sarfaraz Niazi, Sunitha Lokesh. |
| 246 30 - VARYING FORM OF TITLE | |
| Title proper/short title | Regulatory processes. |
| 264 #1 - PRODUCTION, PUBLICATION, DISTRIBUTION, MANUFACTURE, AND COPYRIGHT NOTICE | |
| Place of production, publication, distribution, manufacture | Bristol [England] (Temple Circus, Temple Way, Bristol BS1 6HG, UK) : |
| Name of producer, publisher, distributor, manufacturer | IOP Publishing, |
| Date of production, publication, distribution, manufacture, or copyright notice | [2021] |
| 300 ## - PHYSICAL DESCRIPTION | |
| Extent | 1 online resource (various pagings) : |
| Other physical details | illustrations (some color). |
| 336 ## - CONTENT TYPE | |
| Content type term | text |
| Source | rdacontent |
| 337 ## - MEDIA TYPE | |
| Media type term | electronic |
| Source | isbdmedia |
| 338 ## - CARRIER TYPE | |
| Carrier type term | online resource |
| Source | rdacarrier |
| 490 1# - SERIES STATEMENT | |
| Series statement | [IOP release $release] |
| 490 1# - SERIES STATEMENT | |
| Series statement | IOP ebooks. [2021 collection] |
| 500 ## - GENERAL NOTE | |
| General note | "Version: 202112"--Title page verso. |
| 504 ## - BIBLIOGRAPHY, ETC. NOTE | |
| Bibliography, etc. note | Includes bibliographical references. |
| 505 0# - FORMATTED CONTENTS NOTE | |
| Formatted contents note | 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 |
| 505 8# - FORMATTED CONTENTS NOTE | |
| Formatted contents note | 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 |
| 505 8# - FORMATTED CONTENTS NOTE | |
| Formatted contents note | 3. Gene and cell therapy -- 3.1. Overview -- 3.2. Gene therapy -- 3.3. Cell therapy -- 3.4. Regulatory considerations -- 3.5. Conclusion |
| 505 8# - FORMATTED CONTENTS NOTE | |
| Formatted contents note | 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 |
| 505 8# - FORMATTED CONTENTS NOTE | |
| Formatted contents note | 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 |
| 505 8# - FORMATTED CONTENTS NOTE | |
| Formatted contents note | 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 |
| 505 8# - FORMATTED CONTENTS NOTE | |
| Formatted contents note | 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. |
| 520 3# - SUMMARY, ETC. | |
| Summary, etc. | 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. |
| 521 ## - TARGET AUDIENCE NOTE | |
| Target audience note | Industry scientists, engineers, investors, developers and other manufacturers of biopharmaceutical products. |
| 530 ## - ADDITIONAL PHYSICAL FORM AVAILABLE NOTE | |
| Additional physical form available note | Also available in print. |
| 538 ## - SYSTEM DETAILS NOTE | |
| System details note | Mode of access: World Wide Web. |
| 538 ## - SYSTEM DETAILS NOTE | |
| System details note | System requirements: Adobe Acrobat Reader, EPUB reader, or Kindle reader. |
| 545 ## - BIOGRAPHICAL OR HISTORICAL DATA | |
| Biographical or historical data | 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. |
| 588 0# - SOURCE OF DESCRIPTION NOTE | |
| Source of description note | Title from PDF title page (viewed on January 18, 2022). |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name entry element | Pharmaceutical biotechnology. |
| 9 (RLIN) | 14618 |
| 650 12 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name entry element | Technology, Pharmaceutical. |
| 9 (RLIN) | 8637 |
| 650 12 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name entry element | Biotechnology. |
| 9 (RLIN) | 7533 |
| 650 #7 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name entry element | Pharmaceutical technology. |
| Source of heading or term | bicssc |
| 9 (RLIN) | 7812 |
| 650 #7 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name entry element | Biomedical engineering. |
| Source of heading or term | bisacsh |
| 9 (RLIN) | 3292 |
| 700 1# - ADDED ENTRY--PERSONAL NAME | |
| Personal name | Lokesh, Sunitha, |
| Relator term | author. |
| 9 (RLIN) | 70327 |
| 710 2# - ADDED ENTRY--CORPORATE NAME | |
| Corporate name or jurisdiction name as entry element | Institute of Physics (Great Britain), |
| Relator term | publisher. |
| 9 (RLIN) | 11622 |
| 776 08 - ADDITIONAL PHYSICAL FORM ENTRY | |
| Relationship information | Print version: |
| International Standard Book Number | 9780750331739 |
| -- | 9780750331760 |
| 830 #0 - SERIES ADDED ENTRY--UNIFORM TITLE | |
| Uniform title | IOP (Series). |
| Name of part/section of a work | Release 21. |
| 9 (RLIN) | 70328 |
| 830 #0 - SERIES ADDED ENTRY--UNIFORM TITLE | |
| Uniform title | IOP ebooks. |
| Name of part/section of a work | 2021 collection. |
| 9 (RLIN) | 70329 |
| 856 40 - ELECTRONIC LOCATION AND ACCESS | |
| Uniform Resource Identifier | <a href="https://iopscience.iop.org/book/978-0-7503-3175-3">https://iopscience.iop.org/book/978-0-7503-3175-3</a> |
| 942 ## - ADDED ENTRY ELEMENTS (KOHA) | |
| Koha item type | eBooks |
No items available.