Laboratory of Immunobiochemistry Site Visit.ppt

Regulatory correlates of LIB’s research program(see Briefing Document, p.15) Laboratory of Immunobiochemistry Site Visit Ronald L. Rabin, MD FDA/CBER/OVRR/DBPAP November 4, 2010 */25 Laboratory of Immunobiochemistry (LIB) LIB supports the regulatory mission of CBER and FDA in assuring the safety and efficacy of allergenic products in the US original research directed research projects expert advice lot release data BLA and IND review */25 History of LIB Laboratory of Allergenic Products, Division of Bacterial Products Laboratory of Immunobiochemistry, Division of Allergenic Products and Parasitology Allergenic Products Testing Lab Allergenic Products Research Lab Laboratory of Immunobiochemistry, Division of Bacterial, Parasitic, and Allergenic Products */25 Natural allergen extracts Complex mixtures of allergenic proteins, based largely on an unselective aqueous extraction of natural source material (pollens, insects, animals, foods, venoms) Used for Diagnosis (allergy skin testing) and Allergen immunotherapy Documented efficacy in the immunotherapy of allergic disease due to hymenoptera, ragweed, grass, cat, and dust mite allergen exposure */25 Natural allergen extracts Non-standardized products (n 1000) Unitage uninformative (PNU/mL or w/v) Standardized products (n = 19) unitage correlates to biological potency mass units, BAU/mL, specific allergen controlled for potency and stability based on identity to US standard constitute a small minority of product number, but a greater percentage of product volume */25 How can we improve the use of natural allergen extracts? Increase the number of standardized products Improve the standardization of some current products by improving the definition of the measured allergens Increase purity standards selective extraction techniques, purification Improve characterization methods */25 Recombinant / engineered allergens Current: Potent research tools dissect immune responses modify immune responses study allerg