Strategic selection and development of immunogenicity binding methods

The principal components of a meaningful immunogenicity program consist of an initial binding screen followed by confirmation and quantitation of the positive samples. This comprehensive article first describes evolving technologies and assay formats that encourage scientists to start development with appropriate analytical goals that are specific to their clinical program. The selection of the technology and format is based primarily on the product's structure, treatment indication, intended treatment schedule and pharmacokinetic profile. Feasibility studies are described to satisfy specific criteria before proceeding to optimization. Preparation procedures and storage conditions of critical reagents and controls are provided that will render them suitable throughout the length of the project. A multifactor approach to robustness is recommended that assures consistently sensitive, accurate, precise and specific methods that are verified during prevalidation experiments. Finally, a checklist itemizes all the requirements to develop a compliant validation protocol.