Developing Immunoassays

Evolution of Techniques, Commercial Tools, and IVD Immunoassays
Erscheinungsjahr 2022
ISBN: 978-0-12-824310-7
Verlag: Elsevier Science

Buch, Englisch, 365 Seiten, Format (B × H): 152 mm x 229 mm

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.

Dixit, Chandra K

Fachgebiete

• Naturwissenschaften Chemie Analytische Chemie
• Interdisziplinäres Wissenschaften Wissenschaften: Forschung und Information Forschungsmethodik, Wissenschaftliche Ausstattung

Inhaltsverzeichnis

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

Über Autor(innen)

Dixit, Chandra K
Dr. Chandra Dixit PHD is a Senior Scientist at PBL Assay Science leading new products based on immunoassays for disease diagnostics. Prior he worked at a leading IVD manufacturer Qiagen Sciences in the areas of IVD and nano diagnostics. He received a MSc Biotechnology degree in the year 2004 after which worked in research institutions for 4 years before joining doctoral program. He was awarded a PhD in Biotechnology from Dublin City University in 2012. He spent over 5 years as various Postdoctoral roles at Dublin City University Ireland, Technion IIT Israel, and University of Connecticut USA in areas of microfluidic tools, glycobiology, cell biology, disease diagnosis, electrochemistry, prostate cancer, 3D-printed tools for fluidic devices, and novel nanomaterials. He has published in total of over 45 international research papers including reviews, books, and book chapters in the areas of immune bioanalytical methods, biosensors, conventional and 3D-printed microfluidics, and disease diagnostics. He has also won several reputed international fellowships including the Marie-Curie grant. Currently, he serves in the editorial boards of several journals.