Sterilization of Biosensors
First Claim
1. A method of making a sterilized biosensor, said biosensor comprising at least one binding reagent, said binding reagent comprising at least one non-enzyme proteinaceous binding domain, said method comprising a) partially assembling components of said biosensor, except for said binding reagent, and sterilizing said partial assemblage;
- b) sterilizing, said binding reagent separately from said partial assemblage; and
c) aseptically assembling said sterilized binding reagent with said sterilized partial assemblage to produce said sterilized biosensor, wherein said assembled, sterilized biosensor is capable of providing accurate concentration measurements of at least one analyte.
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Abstract
The present invention relates to methods of making a sterilized biosensor, where the biosensor comprises at least one binding reagent, which comprises at least one non-enzyme proteinaceous binding domain. Certain embodiments of the methods described herein comprise partially assembling the components of the biosensor, except for the binding reagent, and separately sterilizing this partial assemblage and the binding reagent. The sterilized binding reagent and the sterilized partial assemblage are then aseptically assembled to produce the sterilized biosensor. Other embodiments of the methods described herein comprise assembling substantially all of the components of the biosensor, including the binding reagent, and sterilizing the assembled biosensor to produce a sterilized biosensor.
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Citations
20 Claims
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1. A method of making a sterilized biosensor, said biosensor comprising at least one binding reagent, said binding reagent comprising at least one non-enzyme proteinaceous binding domain, said method comprising
a) partially assembling components of said biosensor, except for said binding reagent, and sterilizing said partial assemblage; -
b) sterilizing, said binding reagent separately from said partial assemblage; and
c) aseptically assembling said sterilized binding reagent with said sterilized partial assemblage to produce said sterilized biosensor, wherein said assembled, sterilized biosensor is capable of providing accurate concentration measurements of at least one analyte. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16)
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17. A method of making a sterilized biosensor, said method comprising
a) assembling components of said biosensor, said biosensor comprising at least one binding reagent, said binding reagent comprising at least one non-enzyme proteinaceous binding domain entrapped in a matrix, to produce an unsterilized biosensor, and b) sterilizing said assembled biosensor, said sterilization of said assembled biosensor comprising a type of sterilization selected from the group consisting of electron beam radiation gamma radiation and ethylene oxide; - and,
wherein said assembled, sterilized biosensor is capable of providing accurate concentration measurements of at least one analyte. - View Dependent Claims (18)
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19. A method of increasing or preserving the luminescence signal responsiveness of a sterilized biosensor, said biosensor comprising at least one binding reagent, said binding reagent comprising at least one non-enzyme proteinaceous binding domain, said method comprising at least one step selected from the group consisting of:
- (a) entrapping said binding reagent in a matrix prior to sterilizing said binding reagent, and (b) drying said binding reagent prior to sterilizing said binding reagent.
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20. A sterilized binding reagent comprising at least one sterilized non-enzyme proteinaceous binding domain entrapped in a matrix, said sterilized binding domain being capable of changing three-dimensional conformations upon binding an analyte.
Specification