| 主权项 |
1. A method of using a thermostable kinase for validating a treatment process for reducing the amount or activity of a contaminant in a sample, comprising the steps of:
(a) obtaining a sample that contains or is suspected to contain the contaminant, wherein the contaminant comprises at least one member selected from the group consisting of bacteria, viruses, fungi, toxins, allergens, prions, proteins, and nucleic acids; (b) subjecting the sample to a treatment process in the presence of a defined amount of a biological process indicator comprising the thermostable kinase covalently linked to a biological component,
wherein the treatment process comprises an exposure to at least one member selected from the group consisting of pH, temperature, pressure, enzyme, detergent, chemical sterilant, gas-phase sterilant, and high-temperature autoclaving with steam,wherein the biological component consists of a molecule that mimics the sensitivity of the contaminant to the treatment process,wherein the thermostable kinase has a reference activity, as measured by a luminometer or luminescent assay, that is at least 1,000,000 Relative Light Units (RLU) per mg kinase prior to the treatment process, andwherein the thermostable kinase and the biological component are products of recombinant expression in bacteria; (c) measuring the residual kinase activity after the treatment, wherein kinase activity, as measured by a luminometer or luminescent assay, is reduced by at least 800,000 RLU per mg kinase, wherein said measuring generates a data set; and (d) comparing said residual kinase activity to the reference kinase activity, wherein the reduction in the kinase activity correlates to a treatment-induced reduction in the amount or activity of the contaminant. |
