An edition of Process validation in manufacturing of biopharmaceuticals
(2012)
Process validation in manufacturing of biopharmaceuticals
3rd ed.
by Anurag S. Rathore and G. K. Sofer
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Subjects
Biopharmaceutics, Quality Control, Drug Approval, Biotechnology, Pharmaceutical biotechnology, Biotechnological process monitoring, Quality control, Medicine, Pharmacy, Procédés biotechnologiques, Surveillance, Biotechnologie pharmaceutique, Qualité, Contrôle, Médecine, Biopharmacie, Biotechnologie, Medicines (material), Bioengineering, MEDICAL, Drug Guides, Nursing, PharmacologyShowing 1 featured edition. View all 1 editions?
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Process validation in manufacturing of biopharmaceuticals
2012, Taylor & Francis/CRC Press, CRC Press
in English
- 3rd ed.
1439850933 9781439850930
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Book Details
Table of Contents
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.].
Edition Notes
Includes bibliographical references and index.
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| December 15, 2022 | Edited by MARC Bot | import existing book |
| August 15, 2020 | Edited by ImportBot | import existing book |
| July 6, 2019 | Edited by MARC Bot | import existing book |
| March 15, 2012 | Created by LC Bot | import new book |