Developing Immunoassays

Immunoassay research suffers from a lack of cohesion between academia and industrial development. Academic study of immunoassays is not well-aligned with modern industrial development, leading to high inconsistency. Likewise, industrial developers often lack a holistic understanding of how the tests work. This lack of cohesion is limiting the potential of immunoassay development. Developing Immunoassays: Evolution of Techniques, Commercial Tools, and IVD immunoassays connects fundamental knowledge to real-world applications in regulated and unregulated industry settings. Developing Immunoassays 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. Includes scientific knowledge relevant to immunoassay development for industry professionalsCovers details of risks and possible mitigations introducing 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