Related Experiment Video
Updated: Jul 16, 2026
10:22
Humanized Mediator Release Assay as a Read-Out for Allergen Potency
Published on: June 29, 2021
Recombinant and modified allergens: the U.S. perspective
1US Food and Drug Administration, Center for Biologics Evaluation, Rockville, MD 20852, USA.
Arbeiten Aus Dem Paul-Ehrlich-Institut (Bundesamt Fur Sera Und Impfstoffe) Zu Frankfurt A.M
|March 31, 2007
Abstract:
Since allergenicity and antigenicity (potency) are no longer equivalent, one must scientifically justify modifications and demonstrate (a) loss of allergenicity by standard methods, (b) potency with animal and clinical studies, as well as surrogate markers for clinical efficacy, and (c) biochemical and biologic stability.
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