Importance

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Abstract

A material comprising a biologically active substance (or ligand) to be sterilized, including proteins (e.g., antibodies and enzymes), peptides, DNA, RNA, and glycoproteins, with or without a carrier, and sterilization-protecting agent comprising a trisaccharide or higher saccharide ('polysaccharide') having a positive charge, is provided. The skeletal background of the polysaccharide confers stability to the ligand and its positive charge traps destructive radicals produced during the sterilization process. The molecular weight ratio of sterilization-protecting agent to the ligand should be at least 1/500 but less than 1/2 to protect the ligand effectively without obstructing the ligand's activity. In particular, polysaccharides, such as chitosan (a polymer of D-glucosamine) and chitin which is partially converted into chitosan, are preferable as a sterilization-protecting agent. The biologically active substance in such a material is stabilized against various sterilization methods, including irradiation, wet heat, and chemical sterilization, either in a wet state or a dry state. Further, a method for sterilizing a biologically active substance in the presence of the above-described sterilization-protecting agent is provided.

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First Claim