Buch, Englisch, 365 Seiten, Format (B × H): 152 mm x 229 mm
Evolution of Techniques, Commercial Tools, and IVD Immunoassays
Buch, Englisch, 365 Seiten, Format (B × H): 152 mm x 229 mm
ISBN: 978-0-12-824310-7
Verlag: Elsevier Science
Developing Immunoassays: Evolution of Techniques, Commercial Tools, and IVD Immunoassays connects fundamental knowledge to real-world applications in regulated and unregulated industry settings. The book describes key methods and regulatory standards for building immunoassays in the IVD market. It will serve as a useful reference to experienced developers and will allow students and those who are new to the field to build immunoassays even with little prior knowledge. As immunoassay research suffers from a lack of cohesion between academia and industrial development, this book creates a roadmap to join the two sectors in a unified approach.
Autoren/Hrsg.
Fachgebiete
Weitere Infos & Material
Part 1: Immunoassay Fundamentals1. Immunoassays2. Analytes and Antigens: Fundamental Understanding3. Antibodies4. Detector/Reporter Reagents: Enzymes, Tags, Beads5. Surfaces and Surface Blockers6. Immobilization and ConjugationPart 2: Guide to Develop AntibodiesPart 3: Guide to Develop Immunoassay7. Characterizing Analyte and Antibodies8. Surface blocking and Cross-reactivity9. Analyte-Antibody Interactions10. Antibody Pairing11. Sandwich Assay12. Reagent Designing and Formulations13. Matrix Compliance14. Verification15. Pilot Scale16. Qualification17. Validation18. Immunoassay Formats - ELISA, Cell-based Assays, FACS, ICC, IHCPart 4: Technology and Automation18. Technologies: Agilent, Bio-Techne, Singulex, Thermo-Luminex, Quanterix, MSD, Roche, BD, Beckman Coulter19. Automation: Tecan, Hamilton, Dynex, Siemens, Abbott, Randox, Bioscale, BioTek, Gyros, Hudson Robotics, Thermo, Titertek-BertholdPart 5: IVD Space20. Design Control21. Decision Making: Stage/Phase Gating (idea to product launch and life cycle)22. Regulatory Compliance: FDA, CE, ISO14385, RUO23. cGMPPart 6: IVD Immunoassays24. Molecular Diagnostics MDx - Infectious Diseases25. MDx - Small Molecules (Drugs, Toxins, Hormones and others)26. Companion Diagnostics CDx