Table of contents - GMP-Verlag
Table of contents - GMP-Verlag
Table of contents - GMP-Verlag
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ContentsxiTest Protocol for BIs Biovalidation and Preliminary Study 266Validation <strong>of</strong> Short Incubation Period BIs Validation 268Discussion 269Conclusion 269Moving from Data to Knowledge 269Future Directions 270References 272About the Author 27211. Detection <strong>of</strong> Microbial Contamination for Cell TherapyProducts: Validation <strong>of</strong> an Automated MicrobialDetection System 273Gary C. du Moulin, Grace Kielpinski,Sam Prinzi, John Duguid, and Ann PriceIntroduction 273The Need for Rapid Microbial Detection Methods forCell Therapy 274Carticel: Autologous Cultured Chondrocytes 275Detection Platforms 276Validation Acceptance Criteria 277Selection <strong>of</strong> Microbial Challenge Strains and Preparation<strong>of</strong> Inocula 278Phase 1: Early Stage Validation Studies 279Materials and Methods 280Results 281Phase 2: Test Condition Optimization Studies 282Phase 3: Late Stage Validation Studies 284Results 285Conversion <strong>of</strong> Classic Model to 3D Model Study 286Conversion <strong>of</strong> Glass Bottles to Plastic Bottles Study 287Conclusion 288Acknowledgements 288References 289About the Author 290www.pda.org/bookstore
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