The determination of equivalent doses of standardized allergen标准化变应原等效剂量的测定.pptVIP

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The determination of equivalent doses of standardized allergen标准化变应原等效剂量的测定.ppt

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The determination of equivalent doses of standardized allergen标准化变应原等效剂量的测定

The role of glycerol in allergen extracts Jay E. Slater, MD Laboratory of Immunobiochemistry FDA/CBER/OVRR/DBPAP Glycerol Glycerin Glycerine 1,2,3-propanetriol Trihydroxypropane Solvent Humectant Plasticizer Emollient Sweetener Manufacture of Nitroglycerol Cosmetics Liquid soaps Inks Lubricants Glues Cements Why is glycerol added to allergen extracts? Protein stabilizer Protease inhibitor Bacteriostatic How does glycerol stabilize proteins? Freezing point depression Conformational alterations Preferential hydration Domain interface changes Reduction of backbone mobility Changes in association constants Expiry dating Standardized Based on real-time stability Unstandardized CFR 610.53 Glycerol: 50% vs 50% 50% glycerol 50% glycerol or greater Glycerol inhibits particulate formation in allergen extracts In one series of obsevations, particulates appeared in 95% of aqueous extracts but only 50% of glycerinated extracts Particulates in glycerinated extracts are significantly smaller Glycerol is a preservative “Products in multiple-dose containers shall contain a preservative, except that a preservative need not be added to…an Allergenic Product in 50 percent or more volume in volume (v/v) glycerin.” 21 CFR 610.15 Negatives Pain on injection Glycerol dose related Not volume related More negatives Induration (“glycerin button”) Bruising Summary Glycerol Stabilizes allergens, especially at suboptimal temperatures May inhibit proteases Inhibits bacterial growth Inhibits precipitate formation Only real drawback is pain on injection Note: manufacturers may produce more than one vehicle for a product Date of manufacture 18 months 36 months Date of manufacture 36 months 72 months Van Metre et al JACI 1996;97:1033-9