Title:
Process validation in manufacturing of biopharmaceuticals : guidelines, current practices, and industrial case studies
Author:
Rathore, Anurag S. (Anurag Singh), 1973-
ISBN:
9780849398582
Physical Description:
1 online resource (xxi, 578 pages).
Series:
Biotechnology and bioprocessing series ; Volume 29
Contents:
chapter 1 1 -- chapter 2 2 -- chapter 3 Process Characterization -- chapter 4 Scale-Down Models for Purification Processes: Approaches and Applications -- chapter 5 Adventitious Agents: Concerns and Testing for Biopharmaceuticals -- chapter 6 Life Span Studies for Chromatography and Filtration Media -- chapter 7 Validation of a Filtration Step -- chapter 8 Analytical Test Methods for Biological and Biotechnological Products -- chapter 9 Facility Design Issues A Regulatory Perspective -- chapter 10 Validation of Computerized Systems -- chapter 11 11 -- chapter 12 12 -- chapter 13 Process Validation of a Multivalent Bacterial Vaccine: A Novel Matrix Approach -- chapter 14 Viral Clearance Validation: A Case Study.
Electronic Access:
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Library | Material Type | Item Barcode | Shelf Number | Status | Item Holds |
|---|---|---|---|---|---|
Searching... | E-Book | 541836-1001 | RS380 .P76 2005 | Searching... | Searching... |