[EN] GAMMA IRRADIATION OF PROTEIN-BASED PHARMACEUTICAL PRODUCTS<br/>[FR] IRRADIATION GAMMA DE PRODUITS PHARMACEUTIQUES A BASE DE PROTEINE
申请人:AMERICAN NAT RED CROSS
公开号:WO2001087357A2
公开(公告)日:2001-11-22
Methods are disclosed for inactivation of microbial contaminants in proteinaceous materials while preserving the activity of the materials. The proteinaceous material is exposed to gamma radiation at a high dose rate (e.g., ⊃ 3 kiloGray/hour) while in a lyophilized state under conditions which preserve activity of the material. The material may be formulated to contain one or more stabilizers, and/or be lyophlized to a low moisture content (e.g., less than 1.5%) prior to exposure to the gamma radiation.