Monoclonal antibodies : meeting the challenges in manufacturing, formulation, delivery and stability of final drug product / (Record no. 247079)
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| fixed length control field | 06374cam a2200685Ii 4500 |
| 001 - CONTROL NUMBER | |
| control field | ocn908145774 |
| 003 - CONTROL NUMBER IDENTIFIER | |
| control field | OCoLC |
| 005 - DATE AND TIME OF LATEST TRANSACTION | |
| control field | 20190328114811.0 |
| 006 - FIXED-LENGTH DATA ELEMENTS--ADDITIONAL MATERIAL CHARACTERISTICS | |
| fixed length control field | m o d |
| 007 - PHYSICAL DESCRIPTION FIXED FIELD--GENERAL INFORMATION | |
| fixed length control field | cr cnu|||unuuu |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION | |
| fixed length control field | 150429t20152015ne a ob 001 0 eng d |
| 040 ## - CATALOGING SOURCE | |
| Original cataloging agency | N$T |
| Language of cataloging | eng |
| Description conventions | rda |
| -- | pn |
| Transcribing agency | N$T |
| Modifying agency | IDEBK |
| -- | N$T |
| -- | CDX |
| -- | UIU |
| -- | E7B |
| -- | EBLCP |
| -- | YDXCP |
| -- | ABH |
| -- | DEBSZ |
| -- | OCLCF |
| -- | LVT |
| -- | OCLCQ |
| -- | OCLCO |
| -- | OCLCA |
| -- | U3W |
| -- | OCLCO |
| -- | D6H |
| -- | AU@ |
| -- | OCLCO |
| -- | WYU |
| -- | OCLCO |
| -- | OCLCA |
| 019 ## - | |
| -- | 908513516 |
| -- | 1066445011 |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER | |
| International Standard Book Number | 9780081002971 |
| Qualifying information | (electronic bk.) |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER | |
| International Standard Book Number | 0081002971 |
| Qualifying information | (electronic bk.) |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER | |
| Canceled/invalid ISBN | 9780081002964 |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER | |
| Canceled/invalid ISBN | 0081002963 |
| 035 ## - SYSTEM CONTROL NUMBER | |
| System control number | (OCoLC)908145774 |
| Canceled/invalid control number | (OCoLC)908513516 |
| -- | (OCoLC)1066445011 |
| 050 #4 - LIBRARY OF CONGRESS CALL NUMBER | |
| Classification number | QR186.85 |
| 060 00 - NATIONAL LIBRARY OF MEDICINE CALL NUMBER | |
| Classification number | 2015 F-751 |
| 060 10 - NATIONAL LIBRARY OF MEDICINE CALL NUMBER | |
| Classification number | QW 575.5.A6 |
| 072 #7 - SUBJECT CATEGORY CODE | |
| Subject category code | HEA |
| Subject category code subdivision | 039000 |
| Source | bisacsh |
| 072 #7 - SUBJECT CATEGORY CODE | |
| Subject category code | MED |
| Subject category code subdivision | 014000 |
| Source | bisacsh |
| 072 #7 - SUBJECT CATEGORY CODE | |
| Subject category code | MED |
| Subject category code subdivision | 022000 |
| Source | bisacsh |
| 072 #7 - SUBJECT CATEGORY CODE | |
| Subject category code | MED |
| Subject category code subdivision | 112000 |
| Source | bisacsh |
| 072 #7 - SUBJECT CATEGORY CODE | |
| Subject category code | MED |
| Subject category code subdivision | 045000 |
| Source | bisacsh |
| 082 04 - DEWEY DECIMAL CLASSIFICATION NUMBER | |
| Classification number | 616.07/98 |
| 100 1# - MAIN ENTRY--PERSONAL NAME | |
| Personal name | Shire, Steven J., |
| Relator term | author. |
| 245 10 - TITLE STATEMENT | |
| Title | Monoclonal antibodies : meeting the challenges in manufacturing, formulation, delivery and stability of final drug product / |
| Medium | [electronic resource] |
| Statement of responsibility, etc. | Steven J. Shire. |
| 264 #1 - PRODUCTION, PUBLICATION, DISTRIBUTION, MANUFACTURE, AND COPYRIGHT NOTICE | |
| Place of production, publication, distribution, manufacture | Amsterdam : |
| Name of producer, publisher, distributor, manufacturer | Woodhead Publishing is an imprint of Elsevier, |
| Date of production, publication, distribution, manufacture, or copyright notice | 2015 |
| 264 #4 - PRODUCTION, PUBLICATION, DISTRIBUTION, MANUFACTURE, AND COPYRIGHT NOTICE | |
| Date of production, publication, distribution, manufacture, or copyright notice | �2015 |
| 300 ## - PHYSICAL DESCRIPTION | |
| Extent | 1 online resource : |
| Other physical details | illustrations (some color). |
| 336 ## - CONTENT TYPE | |
| Content type term | text |
| Content type code | txt |
| Source | rdacontent |
| 337 ## - MEDIA TYPE | |
| Media type term | computer |
| Media type code | c |
| Source | rdamedia |
| 338 ## - CARRIER TYPE | |
| Carrier type term | online resource |
| Carrier type code | cr |
| Source | rdacarrier |
| 490 1# - SERIES STATEMENT | |
| Series statement | Woodhead publishing series in biomedicine ; |
| Volume/sequential designation | no. 77 |
| 504 ## - BIBLIOGRAPHY, ETC. NOTE | |
| Bibliography, etc | Includes bibliographical references and index. |
| 588 0# - SOURCE OF DESCRIPTION NOTE | |
| Source of description note | Online resource; title from PDF title page (EBSCO, viewed May 4, 2015). |
| 505 0# - FORMATTED CONTENTS NOTE | |
| Formatted contents note | Front Cover; Related titles; Monoclonal Antibodies; Copyright; Contents; List of figures; List of tables; About the author; Preface; 1 -- Introduction; Pharmaceutical development; Development of the API; mAbs as protein therapeutics; Brief review of mAb structure; References; 2 -- Analytical tools used in the formulation and assessment of stability of monoclonal antibodies (mAbs); Analytical methods for evaluation of monoclonal antibody stability; References; 3 -- Stability of monoclonal antibodies (mAbs); Degradation routes in monoclonal antibodies; Chemical degradation; Mechanisms of oxidation. |
| 505 8# - FORMATTED CONTENTS NOTE | |
| Formatted contents note | Nonenzymatic peptide fragmentationNonreducible cross-linking in mAbs; Physical degradation; Exposure to air/water interfaces due to agitation; Use of large-scale pumps in DP unit operations; Filtration; Filling; Adsorption to surfaces; References; 4 -- Formulation of proteins and monoclonal antibodies (mAbs); Formulation of monoclonal antibodies; Buffers for pH control; Ionic strength and tonicity modifiers; Surfactants and surface-active agents; Antioxidants; Protein Stabilizers; References; 5 -- Challenges in the intravenous (IV) administration of monoclonal antibodies (mAbs). |
| 505 8# - FORMATTED CONTENTS NOTE | |
| Formatted contents note | Extractables and leachables from IV bags and impact on protein/mAb stabilityReferences; 6 -- Challenges in the subcutaneous (SC) administration of monoclonal antibodies (mAbs); The challenge of formulating at high concentration; Impact on delivery due to high viscosity at high mAb concentrations; Impact on manufacturing of high-concentration SC formulations due to high viscosity; Bioavailability of a high-concentration mAb formulation for SC delivery; Development of analytical tools for high-concentration formulation development; References. |
| 505 8# - FORMATTED CONTENTS NOTE | |
| Formatted contents note | 7 -- Strategies to deal with challenges of developing high-concentration subcutaneous (SC) formulations for monoclonal antibodies (mAbs)Using existing manufacturing technologies through redesign of equipment or modification of process variables to produce high-con ... ; Development of alternative processes/formulations for manufacturing of high-concentration dosage forms; Using formulation excipients to reduce viscosity; References; 8 -- Development of delivery device technology to deal with the challenges of highly viscous mAb formulations at high concentration. |
| 505 8# - FORMATTED CONTENTS NOTE | |
| Formatted contents note | Using delivery devices to deliver large volume mAb formulations by the subcutaneous routeDelivery of viscous solutions using a prefilled syringe; The technical challenges for device and formulation development; Primary container/closure systems for devices to be used with mAbs; Silicone oil interactions with proteins and mAbs in prefilled syringes; Impact of leachables from prefilled syringe components; Potential interactions with stainless steel needles; Potential problems with tungsten in prefilled syringes; Filling of highly concentrated mAbs into prefilled syringes; References. |
| 505 8# - FORMATTED CONTENTS NOTE | |
| Formatted contents note | 9 -- The molecular basis of high viscosity of monoclonal antibodies (mAbs) at high concentration. |
| 520 ## - SUMMARY, ETC. | |
| Summary, etc. | Monoclonal antibodies (MAbs) are currently the major class of protein bio therapeutic being developed by biotechnology and pharmaceutical companies. Monoclonal Antibodies discusses the challenges and issues revolving around development of a monoclonal antibody produced by recombinant DNA technology into a therapeutic agent. This book covers downstream processing which includes design of processes to manufacture the formulation, formulation design, fill and finish into closure systems and routes of administration. The characterization of the final drug product is covered where the use of biophy. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | Monoclonal antibodies. |
| 650 #7 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | HEALTH & FITNESS |
| General subdivision | Diseases |
| -- | General. |
| Source of heading or term | bisacsh |
| 650 #7 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | MEDICAL |
| General subdivision | Clinical Medicine. |
| Source of heading or term | bisacsh |
| 650 #7 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | MEDICAL |
| General subdivision | Diseases. |
| Source of heading or term | bisacsh |
| 650 #7 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | MEDICAL |
| General subdivision | Evidence-Based Medicine. |
| Source of heading or term | bisacsh |
| 650 #7 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | MEDICAL |
| General subdivision | Internal Medicine. |
| Source of heading or term | bisacsh |
| 650 #7 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | Monoclonal antibodies. |
| Source of heading or term | fast |
| Authority record control number | (OCoLC)fst01025547 |
| 650 12 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | Antibodies, Monoclonal |
| General subdivision | therapeutic use. |
| Authority record control number | (DNLM)D000911Q000627 |
| 650 22 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | Technology, Pharmaceutical. |
| Authority record control number | (DNLM)D013678 |
| 655 #4 - INDEX TERM--GENRE/FORM | |
| Genre/form data or focus term | Electronic books. |
| 655 #0 - INDEX TERM--GENRE/FORM | |
| Genre/form data or focus term | Electronic book. |
| 776 08 - ADDITIONAL PHYSICAL FORM ENTRY | |
| Relationship information | Print version: |
| Main entry heading | Shire, Steven. |
| Title | Monoclonal Antibodies : Meeting the Challenges in Manufacturing, Formulation, Delivery and Stability of Final Drug Product. |
| Place, publisher, and date of publication | Burlington : Elsevier Science, �2015 |
| International Standard Book Number | 9780081002964 |
| 830 #0 - SERIES ADDED ENTRY--UNIFORM TITLE | |
| Uniform title | Woodhead Publishing series in biomedicine ; |
| Volume number/sequential designation | no. 77. |
| 856 40 - ELECTRONIC LOCATION AND ACCESS | |
| Materials specified | ScienceDirect |
| Uniform Resource Identifier | http://www.sciencedirect.com/science/book/9780081002964 |
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