Development of a panel of highly sensitive, equivalent assays for detection of antibody responses to velaglucerase alfa or imiglucerase enzyme replacement therapy in patients with Gaucher disease

► Velaglucerase alfa and imiglucerase are therapies for type 1 Gaucher disease. ► We developed assays to compare antibody response to these two replacement enzymes. ► Screening, confirmatory, isotyping, and neutralizing activity assays were developed. ► State-of-the-art methods and the latest guidance were used to validate the assays. ► The assays facilitate direct comparison of antibody responses to the two enzymes.