Disposable Bioprocessing SystemsWritten 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 |
253 | |
291 | |
Other editions - View all
Common terms and phrases
achieved addition Agents allow antibody Appendix applications aseptic bags biological BioProcess Biosafety biosensors Biotechnol buffer cell culture chromatography columns components containing cost cultivation density described device diaphragm disposable bioreactors drug effect efficient equipment Evaluation experiments expression extractables facility FIGURE filters flasks flexible flow fluid growth human increased industry Institutional integrated involving Laboratory large-scale liquid manufacturing materials measurements mechanical medium membrane method Millipore Corp mixing modules monitoring offers operations organisms oxygen performance peristaltic pharmaceutical plastic pressure production protein provides pump reactor recombinant reduce References removal require result Safety sampling scale Sciences sensors shake similar single-use solutions specific stainless steel standard steps sterile studies surface Taylor & Francis testing transfer tubing tumor unit validation viable virus volume waste Wave Bioreactor yield