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US 2022/0010355 A1Published application
Cell based method for determination of botulinum toxin potency based on western blotting
AssigneeGalderma Holding SA
InventorsEmilia LEKHOLM, Sara JACOBSON, Sofie HELLSTEN, Robert FREDRIKSSON, Anh-Tri DO
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Abstract
Described are cell-based methods for detecting botulinum neurotoxin (BoNT) potency and/or activity in the absence of LD50 assays that rely upon large numbers of laboratory animals.
Claims25
A method of determining potency of botulinum neurotoxins (BoNTs), the method comprising:
- (a) distributing at least two different BoNT samples to at least two containers comprising cells expressing a SNAP25 protein, wherein the first BoNT sample is a reference sample of a known potency and the second BoNT sample is a test sample of unknown potency,
- (b) incubating the cells with the BoNT for a period of time,
- (c) determining the ratio of cleaved SNAP25 protein to uncleaved SNAP25 protein corresponding to the reference sample and the test sample, and
- (d) identifying the potency of the test sample relative to the reference sample.
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Dependencies are inferred from the claim text.