Process validation in manufacturing of biopharmaceuticals (Record no. 15016)
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| 000 -LEADER | |
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| fixed length control field | 03085nam a2200361Ia 4500 |
| 001 - CONTROL NUMBER | |
| control field | CRC0KE12351PDF |
| 003 - CONTROL NUMBER IDENTIFIER | |
| control field | FlBoTFG |
| 005 - DATE AND TIME OF LATEST TRANSACTION | |
| control field | 20171224123444.0 |
| 006 - FIXED-LENGTH DATA ELEMENTS--ADDITIONAL MATERIAL CHARACTERISTICS--GENERAL INFORMATION | |
| fixed length control field | m|||||o||d|||||||| |
| 007 - PHYSICAL DESCRIPTION FIXED FIELD--GENERAL INFORMATION | |
| fixed length control field | cr|||| |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION | |
| fixed length control field | 120427s2012 fluad sb 001 0 eng d |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER | |
| International Standard Book Number | 9781439850947 (ebook : PDF) |
| 040 ## - CATALOGING SOURCE | |
| Original cataloging agency | FlBoTFG |
| Transcribing agency | FlBoTFG |
| 090 ## - LOCALLY ASSIGNED LC-TYPE CALL NUMBER (OCLC); LOCAL CALL NUMBER (OCLC) | |
| Classification number (OCLC) (R) ; Classification number, CALL (RLIN) (NR) | RM301.4 |
| Local cutter number (OCLC) ; Book number/undivided call number, CALL (RLIN) | .P76 2012 |
| 092 ## - LOCALLY ASSIGNED DEWEY CALL NUMBER (OCLC) | |
| Classification number | 615.19 |
| Item number | P963 |
| 245 00 - TITLE STATEMENT | |
| Title | Process validation in manufacturing of biopharmaceuticals |
| Medium | [electronic resource] / |
| Statement of responsibility, etc | edited by Anurag S. Rathore, Gail Sofer. |
| 250 ## - EDITION STATEMENT | |
| Edition statement | 3rd ed. |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. (IMPRINT) | |
| Place of publication, distribution, etc | Boca Raton : |
| Name of publisher, distributor, etc | CRC Press, |
| Date of publication, distribution, etc | 2012. |
| 300 ## - PHYSICAL DESCRIPTION | |
| Extent | xvii, 513 p. : |
| Other physical details | ill. |
| 490 1# - SERIES STATEMENT | |
| Series statement | Biotechnology and bioprocessing series ; |
| Volume number/sequential designation | 35 |
| 504 ## - BIBLIOGRAPHY, ETC. NOTE | |
| Bibliography, etc | Includes bibliographical references and index. |
| 505 0# - FORMATTED CONTENTS NOTE | |
| Formatted contents note | ch. 1. Guidelines to process validation / Gail Sofer -- ch. 2. Commentary on the US Food and Drug Administration's 2011 "Guidance for industry, process validation general principles and practices" / Hal Baseman -- ch. 3. Applications of failure modes and effects analysis to biotechnology manufacturing processes / Robert J. Seely and John Haury -- ch. 4. Process characterization / James E. Seely -- ch. 5. Scaled-down models for purification processes : approaches and applications / Ranga Godavarti ... [et al.] -- ch. 6. Adventitious agents : concerns and testing for biopharmaceuticals / Raymond W. Nims ... [et al.] -- ch. 7. Lifespan studies for chromatography and filtration media / Anurag S. Rathore and Gail Sofer -- ch. 8. Validation of a filtration step / Jennifer Campbell -- ch. 9. Analytical test methods for well-characterized biological and biotechnological products / Nadine Ritter and John McEntire -- ch. 10. Facility design issues : a regulatory perspective / Susan Vargo and Nancy Kavanaugh -- ch. 11. Validation of computerized systems / Monica J. Cahilly -- ch. 12. Process validation with a CMO / Susan Dana Jones, Sheila G. Magil, and Gail Sofer -- ch. 13. Risk management and validation / James Agalloco -- ch. 14. Process validation in membrane chromatography / Suma Ray and Miyako Hirai -- ch. 15. Leveraging multivariate analysis tools to qualify scaled-down models / John Pieracci and Helena Yusuf-Makagiansar -- ch. 16. Process validation of a multivalent bacterial vaccine : a novel matrix approach / Narahari S. Pujar ... [et al.] -- ch. 17. Validation of the Zevalin purification process : a case study / Lynn Conley, John McPherson, and J�org Th�ommes -- ch. 18. Viral clearance validation : a case study / Michael Rubino ... [et al |
| 530 ## - ADDITIONAL PHYSICAL FORM AVAILABLE NOTE | |
| Additional physical form available note | Also available in print editi |
| 538 ## - SYSTEM DETAILS NOTE | |
| System details note | Mode of access: World Wide W |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | Biopharmaceuti |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | Quality contr |
| 655 ## - INDEX TERM--GENRE/FORM | |
| Genre/form data or focus term | Electronic books. |
| Source of term | l |
| 700 ## - ADDED ENTRY--PERSONAL NAME | |
| Personal name | Rathore, Anurag S. |
| Fuller form of name | (Anurag Singh), |
| Dates associated with a name | 19 |
| 700 ## - ADDED ENTRY--PERSONAL NAME | |
| Personal name | Sofer, G. |
| 776 ## - ADDITIONAL PHYSICAL FORM ENTRY | |
| International Standard Book Number | 9781439850930 (hardcover : alk. pap |
| 830 ## - SERIES ADDED ENTRY--UNIFORM TITLE | |
| Uniform title | Biotechnology and bioprocessing series ; |
| Volume number/sequential designation | |
| 856 ## - ELECTRONIC LOCATION AND ACCESS | |
| Uniform Resource Identifier | http://marc.crcnetbase.com/isbn/9781439850947 |
| Electronic format type | application/PDF |
| Public note | Distributed by publisher. Purchase or institutional license may be required for acce |
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