MARC details
| 000 -LEADER |
|---|
| fixed length control field |
02846cam a22003618a 4500 |
| 001 - CONTROL NUMBER |
|---|
| control field |
17191395 |
| 005 - DATE AND TIME OF LATEST TRANSACTION |
|---|
| control field |
20190509111644.0 |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION |
|---|
| fixed length control field |
120221s2012 flu b 001 0 eng |
| 010 ## - LIBRARY OF CONGRESS CONTROL NUMBER |
|---|
| LC control number |
2012001495 |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER |
|---|
| International Standard Book Number |
9781439850930 (hardcover : alk. paper) |
| 040 ## - CATALOGING SOURCE |
|---|
| Original cataloging agency |
DNLM/DLC |
| Transcribing agency |
DLC |
| Modifying agency |
DLC |
| Description conventions |
rda |
| 082 00 - DEWEY DECIMAL CLASSIFICATION NUMBER |
|---|
| Classification number |
615.19 |
| Edition number |
23 |
| Item number |
P |
| 245 00 - TITLE STATEMENT |
|---|
| Title |
Process validation in manufacturing of biopharmaceuticals / |
| Statement of responsibility, etc |
editors, Anurag 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 |
Taylor & Francis/CRC Press, |
| Date of publication, distribution, etc |
2012. |
| 300 ## - PHYSICAL DESCRIPTION |
|---|
| Extent |
p. ; |
| Dimensions |
cm. |
| 336 ## - CONTENT TYPE |
|---|
| Source |
rdacontent |
| Content type term |
text |
| 337 ## - MEDIA TYPE |
|---|
| Source |
rdamedia |
| Media type term |
unmediated |
| 338 ## - CARRIER TYPE |
|---|
| Source |
rdacarrier |
| Carrier type term |
volume |
| 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 |
Guidelines to process validation / Gail Sofer -- Commentary on the US Food and Drug Administration's 2011 : guidance for industry, process validation general principles, and practices / Hal Baseman -- Applications of failure modes and effects analysis to biotechnology manufacturing processes / Robert J. Seely and John Haury -- Process characterization / James E. Seely -- Scale-down models for purification processes : approaches and applications / Ranga Godavarti ... [et al.] -- Adventitious agents : concerns and testing for biopharmaceuticals / Raymond W. Nims ... [et al.] -- Lifespan studies for chromatography and filtration media / Anurag Rathore and Carol Sofer -- Validation of a filtration step / Jennifer Campbell -- Analytical test methods for well-characterized biological and biotechnological products / Nadine Ritter and John McEntire -- Facility design issues : a regulatory perspective / Sue Vargo -- Validation of computerized systems / Monica J. Cahilly -- Process validation with a CMO / Susan Dana Jones, Sheila G. Magil, and Gail Sofer -- Risk management & validation / James Agalloco -- Process validation in membrane chromatography / Suma Ray, Miyako Hirai, and Stefan Fischer-Fruehholz -- Leveraging multivariate analysis tools to qualify scaled-down models / John Pieracci and Helena Yusuf-Makagiansar -- Process validation of a multivalent bacterial vaccine : a novel -- Matrix approach / Narahari S. Pujar ... [et al.] -- Validation of the Zevalin purification process : a case study / Lynn Conley, John McPherson, and Jörg Thömmes -- Viral clearance validation : a case study / Michael Rubino ... [et al.]. |
| 650 12 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name as entry element |
Biopharmaceutics. |
| 650 22 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name as entry element |
Biotechnology. |
| 650 22 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name as entry element |
Drug Approval. |
| 650 22 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name as entry element |
Quality Control. |
| 700 1# - ADDED ENTRY--PERSONAL NAME |
|---|
| Personal name |
Rathore, Anurag S. |
| Fuller form of name |
(Anurag Singh), |
| Dates associated with a name |
1973- |
| 700 1# - ADDED ENTRY--PERSONAL NAME |
|---|
| Personal name |
Sofer, G. K. |
| 830 #0 - SERIES ADDED ENTRY--UNIFORM TITLE |
|---|
| Uniform title |
Biotechnology and bioprocessing series ; |
| Volume number/sequential designation |
35. |
| 856 ## - ELECTRONIC LOCATION AND ACCESS |
|---|
| Materials specified |
Abstract |
| Uniform Resource Identifier |
<a href="http://repository.fue.edu.eg/xmlui/handle/123456789/1677">http://repository.fue.edu.eg/xmlui/handle/123456789/1677</a> |
| 942 ## - ADDED ENTRY ELEMENTS (KOHA) |
|---|
| Koha item type |
Books |
| Source of classification or shelving scheme |
Dewey Decimal Classification |