Developing Immunoassays: Evolution of Techniques, Commercial Tools, and IVD Immunoassays

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. The book 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. Immunoassay research suffers from a lack of cohesion between academia and industrial development. Academic study of immunoassays is not well-aligned with modern and industrial development, leading to high inconsistency. Likewise, industrial developers often lack a holistic understanding of how the tests work. Includes scientific knowledge relevant to immunoassay development for industry professionalsCovers details of risks and possible mitigations, introducing the FMEA approachDetails the process to develop robust immunoassays, including precise guidelines for design control and stage gatingIncludes typical regulatory guidelines, especially for the IVD landscape INDICE: Part 1: Immunoassay Fundamentals 1. Immunoassays 2. Analytes and Antigens: Fundamental Understanding 3. Antibodies 4. Detector/Reporter Reagents: Enzymes, Tags, Beads 5. Surfaces and Surface Blockers 6. Immobilization and Conjugation Part 2: Guide to Develop Antibodies Part 3: Guide to Develop Immunoassay 7. Characterizing Analyte and Antibodies 8. Surface blocking and Cross-reactivity 9. Analyte-Antibody Interactions 10. Antibody Pairing 11. Sandwich Assay 12. Reagent Designing and Formulations 13. Matrix Compliance 14. Verification 15. Pilot Scale 16. Qualification 17. Validation 18. Immunoassay Formats - ELISA, Cell-based Assays, FACS, ICC, IHC Part 4: Technology and Automation 18. Technologies: Agilent, Bio-Techne, Singulex, Thermo-Luminex, Quanterix, MSD, Roche, BD, Beckman Coulter 19. Automation: Tecan, Hamilton, Dynex, Siemens, Abbott, Randox, Bioscale, BioTek, Gyros, Hudson Robotics, Thermo, Titertek-Berthold Part 5: IVD Space 20. Design Control 21. Decision Making: Stage/Phase Gating (idea to product launch and life cycle) 22. Regulatory Compliance: FDA, CE, ISO14385, RUO 23. cGMP Part 6: IVD Immunoassays 24. Molecular Diagnostics MDx - Infectious Diseases 25. MDx - Small Molecules (Drugs, Toxins, Hormones and others) 26. Companion Diagnostics CDx 

• ISBN: 978-0-12-824310-7
• Editorial: Elsevier
• Encuadernacion: Rústica
• Páginas: 365
• Fecha Publicación: 01/01/2022
• Nº Volúmenes: 1
• Idioma: Inglés