Technology Bundle ID

Potency Assay for Membrane Transporter Protein-based Drugs Acting on Antioxidant, Redox, and Apoptosis Response Pathways

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Lead Inventors
Xiaoyi Yang (NCI)
Trevor Broadt (NCI)
This technology includes a method of analyzing the potency of membrane transporter protein-based drugs acting on intracellular antioxidant and redox response pathways (and associated apoptosis pathways), wherein the drug delivery and activity is lipid associated. The present invention is a cell-based bioassay for measuring the bioactivity of drug substance and formulated drug product by determining the drug's dose-dependent inhibitory effects on 4 hydroxynonenal (4-HNE)-induced antioxidant response element (ARE) activity. The present invention covers use of HEK293 ARE-Luc Stable cell line as the detection system, high-throughput 96-well format, drug dilution approach, enclosure of negative controls with non-relevant heterologous proteins, use of the stimulator 4-HNE, and the optimal measurement time points with the ARE luciferase reporter gene. This is also an effective method to make liposome-drug substance mixtures for assembly of drug substance proteins into cellular membranes by using premade empty liposomes as a drug delivery system.
Commercial Applications
Applications include potency analysis of drug substance and drug product of membrane transporter protein-based drugs, such as RLIP76, acting on antioxidant and redox response pathways during the process, release, and stability monitoring.
Competitive Advantages
This method standardizes the analysis of the potency of RLIP76-based drug substance and drug product in a dose-dependent manner during the manufacturing process, release, and stability monitoring of RLIP76 and similar molecules.

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