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Developing Immunoassays

Evolution of Techniques, Commercial Tools, and IVD Immunoassays

Buch | Softcover

365 Seiten

2022
Elsevier Science Publishing Co Inc (Verlag)
978-0-12-824310-7 (ISBN)

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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.

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.

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

Erscheint lt. Verlag	1.12.2022
Zusatzinfo	Approx. 100 illustrations (100 in full color); Illustrations, unspecified
Sprache	englisch
Maße	152 x 229 mm
Themenwelt	Naturwissenschaften ► Chemie ► Analytische Chemie
ISBN-10	0-12-824310-4 / 0128243104
ISBN-13	978-0-12-824310-7 / 9780128243107
Zustand	Neuware