Disposable Bioprocessing Systems

Front Cover
CRC Press, Apr 19, 2016 - Medical - 322 pages
Written by a researcher with experience designing, establishing, and validating biological manufacturing facilities worldwide, this is the first comprehensive introduction to disposable systems for biological drug manufacturing. It reviews the current state of the industry; tackles questions about safety, costs, regulations, and waste disposal; and guides readers to choose disposable components that meet their needs. This practical manual covers disposable containers, mixing systems, bioreactors, connectors and transfers, controls and sensors, downstream processing systems, filling and finishing systems, and filters. The author also shares his predictions for the future, calling disposable bioprocessing technology a "game changer."
 

Contents

1 The Bioprocessing IndustryAn Introduction
1
2 Safety of Disposable Systems
23
3 Containers
45
4 Mixing Systems
53
5 Disposable Bioreactors
61
6 Connectors and Transfers
121
7 Controls
137
8 Downstream Processing
149
9 Filling and Finishing Systems
169
10 Filtration
179
11 Regulatory Compliance
191
12 Environmental Concerns
203
13 Epilogue
237
Bibliography
253
Index
291
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About the author (2016)

Sarfaraz K. Niazi has been teaching pharmaceutical sciences and conducting research in the field of drug and dosage form development for over 35 years. A former professor at the University of Illinois, Dr. Niazi has written over a hundred papers, dozens of books, and owns dozens of patents for his inventions in the field of drug development and biopharmaceutical processing, including patents on novel bioreactors. His first book on the subject, Handbook of Biogeneric Therapeutic Proteins (CRC Press), was widely received as a primer in the field of biological manufacturing. Niazi has hands-on experience in designing, establishing, and validating biological manufacturing facilities worldwide. He lives in Deerfield, Illinois.