Process validation in manufacturing of biopharmaceuticals : guidelines, current practices, and industrial case studies
by
Rathore, Anurag S. (Anurag Singh), 1973-
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.
Subject Term
:
Pharmaceutical biotechnology -- Quality control.
Biotechnological process monitoring.
Added Author
:
Rathore, Anurag S. (Anurag Singh), 1973-
Sofer, G. K.
Electronic Access
:
| Library | Material Type | Item Barcode | Shelf Number | [[missing key: search.ChildField.HOLDING]] | Status |
|---|
| Online Library | E-Book | 541836-1001 | RS380 .P76 2005 | | CRC E-Books |