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Preface | p. ix |
Editors | p. xiii |
Contributors | p. xv |
Guidelines to Process Validation | p. 1 |
Commentary on the US Food and Drug Administration's 2011 "Guidance for Industry, Process Validation General Principles and Practices" | p. 11 |
Applications of Failure Modes and Effects Analysis to Biotechnology Manufacturing Processes | p. 51 |
Process Characterization | p. 63 |
Scaled-Down Models for Purification Processes: Approaches and Applications | p. 89 |
Adventitious Agents: Concerns and Testing for Biopharmaceuticals | p. 141 |
Lifespan Studies for Chromatography and Filtration Media | p. 159 |
Validation of a Filtration Step | p. 185 |
Analytical Test Methods for Well-Characterized Biological and Biotechnological Products | p. 235 |
Facility Design Issues: A Regulatory Perspective | p. 269 |
Validation of Computerized Systems | p. 313 |
Process Validation with a CMO | p. 355 |
Risk Management and Validation | p. 375 |
Process Validation in Membrane Chromatography | p. 385 |
Leveraging Multivariate Analysis Tools to Qualify Scaled-Down Models | p. 411 |
Process Validation of a Multivalent Bacterial Vaccine: A Novel Matrix Approach | p. 441 |
Validation of the Zevalin® Purification Process: A Case Study | p. 455 |
Viral Clearance Validation: A Case Study | p. 491 |
Index | p. 503 |
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The New copy of this book will include any supplemental materials advertised. Please check the title of the book to determine if it should include any access cards, study guides, lab manuals, CDs, etc.
The Used, Rental and eBook copies of this book are not guaranteed to include any supplemental materials. Typically, only the book itself is included. This is true even if the title states it includes any access cards, study guides, lab manuals, CDs, etc.