Recombinant and modified allergens: the U.S. perspective.
US Food and Drug Administration, Center for Biologics Evaluation, Rockville, MD 20852, USA.Arbeiten aus dem Paul-Ehrlich-Institut (Bundesamt für Sera und Impfstoffe) zu Frankfurt a.M 01/2006;
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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