Methods for sterilizing materials containing biologically active agents
AssigneeDePuy Synthes Products, Inc.
InventorsAlexander M. Harmon, Laura J. Brown, Charles J. Buckle, Frederick Halperin, Stanko Bodnar
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Abstract
Provided are methods for sterilizing a material comprising a biologically-active agent comprising irradiating said material with ionizing radiation at a dose of about 5 kGy to about 25 kGy while maintaining said material in an atmosphere comprising at least 95% by volume inert gas and at a temperature of about 4° C. or lower. Also provided are sterilized materials comprising a biologically-active agent, wherein said materials exhibit substantially the same amount of biological activity as a non-sterilized control.
Claims16
An irradiation-sterilized, stabilizer-free, human umbilical tissue-derived cell (hUTC) lysate composition comprising hUTC lysate sterilized by irradiating with ionizing radiation at a dose in the range of from about 5 kGy to about 25 kGy in an atmosphere comprising at least 95% by volume inert gas and at a temperature of about 4° C. or lower without the addition of a stabilizer, and wherein the biological activity of the hUTC lysate is retained after sterilization.
An irradiation-sterilized, stabilizer-free, human umbilical tissue-derived cell (hUTC) lysate composition comprising hUTC lysate sterilized with ionizing radiation in the absence of a stabilizer, and wherein the biological activity of the hUTC lysate is retained after sterilization.
Dependencies are inferred from the claim text.