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

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Book
January 2022
Elsevier Science and Technology
ID: 5390190

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.

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

Authors

Chandra K. Dixit Senior Scientist, PBL Assay Science. 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.

Table of Contents

Authors

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