|
|
|
|
| LEADER |
01000cam a2200265 4500 |
| 001 |
688225101 |
| 003 |
DE-627 |
| 005 |
20230905072202.0 |
| 007 |
tu |
| 008 |
120308s2012 xxu||||| 00| ||eng c |
| 010 |
|
|
|a 2012001495
|
| 020 |
|
|
|a 9781439850930
|c hardcover : alk. paper
|9 978-1-4398-5093-0
|
| 035 |
|
|
|a (DE-627)688225101
|
| 035 |
|
|
|a (DE-599)GBV688225101
|
| 035 |
|
|
|a (OCoLC)807011578
|
| 040 |
|
|
|a DE-627
|b ger
|c DE-627
|e rakwb
|
| 041 |
|
|
|a eng
|
| 044 |
|
|
|c XD-US
|c XA-GB
|
| 050 |
|
0 |
|a RS380
|
| 060 |
|
0 |
|a QV 38
|
| 082 |
0 |
|
|a 615.1/9
|q LOC
|2 23
|
| 084 |
|
|
|a 15,3
|2 ssgn
|
| 084 |
|
|
|a 58.30
|2 bkl
|
| 084 |
|
|
|a 58.28
|2 bkl
|
| 245 |
1 |
0 |
|a Process validation in manufacturing of biopharmaceuticals
|c ed. by Anurag S. Rathore; Gail Sofer
|
| 250 |
|
|
|a 3. ed.
|
| 263 |
|
|
|a 1203
|
| 264 |
|
1 |
|a Boca Raton, Fla. [u.a.]
|b Taylor & Francis/CRC Press
|c 2012
|
| 300 |
|
|
|a XVII, 513 S.
|b graph. Darst.
|c cm
|
| 336 |
|
|
|a Text
|b txt
|2 rdacontent
|
| 337 |
|
|
|a ohne Hilfsmittel zu benutzen
|b n
|2 rdamedia
|
| 338 |
|
|
|a Band
|b nc
|2 rdacarrier
|
| 490 |
1 |
|
|a Biotechnology and bioprocessing series
|v 35
|
| 500 |
|
|
|a Includes bibliographical references and index
|
| 505 |
8 |
0 |
|a Guidelines to process validation / Gail SoferCommentary 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.].
|
| 505 |
8 |
0 |
|t Guidelines to process validation
|r Gail Sofer
|
| 505 |
8 |
0 |
|t Commentary on the US Food and Drug Administration's 2011 : guidance for industry, process validation general principles, and practices
|r Hal Baseman
|
| 505 |
8 |
0 |
|t Applications of failure modes and effects analysis to biotechnology manufacturing processes
|r Robert J. Seely and John Haury
|
| 505 |
8 |
0 |
|t Process characterization
|r James E. Seely
|
| 505 |
8 |
0 |
|t Scale-down models for purification processes : approaches and applications
|r Ranga Godavarti ... [et al.]
|
| 505 |
8 |
0 |
|t Adventitious agents : concerns and testing for biopharmaceuticals
|r Raymond W. Nims ... [et al.]
|
| 505 |
8 |
0 |
|t Lifespan studies for chromatography and filtration media
|r Anurag Rathore and Carol Sofer
|
| 505 |
8 |
0 |
|t Validation of a filtration step
|r Jennifer Campbell
|
| 505 |
8 |
0 |
|t Analytical test methods for well-characterized biological and biotechnological products
|r Nadine Ritter and John McEntire
|
| 505 |
8 |
0 |
|t Facility design issues : a regulatory perspective
|r Sue Vargo
|
| 505 |
8 |
0 |
|t Validation of computerized systems
|r Monica J. Cahilly
|
| 505 |
8 |
0 |
|t Process validation with a CMO
|r Susan Dana Jones, Sheila G. Magil, and Gail Sofer
|
| 505 |
8 |
0 |
|t Risk management & validation
|r James Agalloco
|
| 505 |
8 |
0 |
|t Process validation in membrane chromatography
|r Suma Ray, Miyako Hirai, and Stefan Fischer-Fruehholz
|
| 505 |
8 |
0 |
|t Leveraging multivariate analysis tools to qualify scaled-down models
|r John Pieracci and Helena Yusuf-Makagiansar
|
| 505 |
8 |
0 |
|t Process validation of a multivalent bacterial vaccine : a novel ; Matrix approach
|r Narahari S. Pujar ... [et al.]
|
| 505 |
8 |
0 |
|t Validation of the Zevalin purification process : a case study
|r Lynn Conley, John McPherson, and Jörg Thömmes
|
| 505 |
8 |
0 |
|t Viral clearance validation : a case study
|r Michael Rubino ... [et al.].
|
| 650 |
|
2 |
|a Biopharmaceutics
|
| 650 |
|
2 |
|a Biotechnology
|
| 650 |
|
2 |
|a Drug Approval
|
| 650 |
|
2 |
|a Quality Control
|
| 689 |
0 |
0 |
|D s
|0 (DE-588)7689632-8
|0 (DE-627)618407677
|0 (DE-576)318506688
|a Biologika
|2 gnd
|
| 689 |
0 |
1 |
|D s
|0 (DE-588)4045699-7
|0 (DE-627)104162406
|0 (DE-576)209066407
|a Pharmazeutische Technologie
|2 gnd
|
| 689 |
0 |
2 |
|D s
|0 (DE-588)4187357-9
|0 (DE-627)105272787
|0 (DE-576)210045248
|a Validierung
|2 gnd
|
| 689 |
0 |
|
|5 (DE-627)
|
| 700 |
1 |
|
|a Rathore, Anurag Singh
|d 1973-
|4 oth
|
| 700 |
1 |
|
|a Sofer, Gail K.
|4 oth
|
| 830 |
|
0 |
|a Biotechnology and bioprocessing series
|v 35
|9 35
|w (DE-627)510224776
|w (DE-576)094635102
|w (DE-600)2230620-1
|x 0888-7470
|7 ns
|
| 856 |
4 |
2 |
|u http://www.gbv.de/dms/bs/toc/688225101.pdf
|m V:DE-601
|m B:DE-84
|q pdf/application
|v 2012-12-24
|x Verlag
|y Inhaltsverzeichnis
|3 Inhaltsverzeichnis
|
| 912 |
|
|
|a GBV_ILN_70
|
| 912 |
|
|
|a ISIL_DE-89
|
| 912 |
|
|
|a SYSFLAG_1
|
| 912 |
|
|
|a GBV_KXP
|
| 912 |
|
|
|a SSG-OLC-PHA
|
| 912 |
|
|
|a SSG-OPC-PHA
|
| 912 |
|
|
|a SSG-OPC-DE-84
|
| 936 |
b |
k |
|a 58.30
|j Biotechnologie
|0 (DE-627)106405365
|
| 936 |
b |
k |
|a 58.28
|j Pharmazeutische Technologie
|0 (DE-627)106417622
|
| 951 |
|
|
|a BO
|
| 953 |
|
|
|2 045F
|a 615.1/9
|
| 980 |
|
|
|2 70
|1 01
|x 0089
|b 1400482380
|c 00
|f Haus2
|d RA 7661(35),3
|e u
|j --%%--
|y z
|z 14-06-13
|
| 984 |
|
|
|2 70
|1 01
|x 0089
|a 89$136779530
|
