Biotechnology: Quality Assurance and Validation

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Kenneth E. Avis, Carmen M. Wagner, Vincent L. Wu
CRC Press, Oct 31, 1998 - Medical - 288 pages
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Biotechnology: Quality Assurance and Validation provides a practical, detailed discussion of what issues Quality Assurance and Quality Control need to identify for effective control in the preparation of biotechnology products. The book presents a series of topics that define some of the unique challenges facing biotechnology companies in producing biopharmaceutical products. The topics selected address quality and validation issues, starting with the cryopreservation of cell lines through the filling and finishing of the product. It includes a validation guide, a clear presentation of how to use filtration effectively, a synoptic view of cleaning procedures, and much more.
 

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Contents

Introduction
1
Storage
7
Characterization
11
Inventory
17
Data Management
26
Quality Control and Quality Assurance
33
Special Concerns for Biotechnology Products
43
Future Trends
63
Ensuring Virological Safety
167
Sources of Viral Contamination
173
Regulatory Considerations in Viral Clearance
184
Model Viruses Used in Process Validation
190
Validation of Viral Clearance
196
Direct Flow Filtration
198
Positioning of Viral Clearance Methodologies
208
Cleaning and Validation of Cleaning
221

Strategies for Compliance
98
Conclusion
105
Validation
111
Validation of FermentationCell Culture Processes
128
Column Lifetime
134
Validation of Tangential Flow Filtration
154
Cleaning Validation
234
Current and Future Trends in Cleaning
249
Index
251
Drug Manufacturing Technology Series
266
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