Developing 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. 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.

• Includes scientific knowledge relevant to immunoassay development for industry professionals
• Covers details of risks and possible mitigations, introducing the FMEA approach
• Details the process to develop robust immunoassays, including precise guidelines for design control and stage gating
• Includes typical regulatory guidelines, especially for the IVD landscape