Recombinant and modified allergens: the U.S. perspective.
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.
Rabin
Ronald L
RL
US Food and Drug Administration, Center for Biologics Evaluation, Rockville, MD 20852, USA.
D000485:Allergens / Q000276:immunology*; D000818:Animals; D003888:Desensitization, Immunologic / Q000592:standards*; D006801:Humans; D011994:Recombinant Proteins / Q000276:immunology*; D051193:Toll-Like Receptors / Q000502:physiology
D000485:Allergens; D011994:Recombinant Proteins; D051193:Toll-Like Receptors