Last Updated: July 27, 2026

Claims for Patent: 10,921,312

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Summary for Patent: 10,921,312

Title:	Gangliosides for standardizing and increasing the sensitivity of cells to botulinum neurotoxins in in vitro test systems
Abstract:	The present invention pertains to a method for standardizing the sensitivity of induced pluripotent stem cell (iPS)-derived neurons to a neurotoxin polypeptide, comprising the steps of: a) cultivating different batches of induced pluripotent stem cell-derived neurons in a cell culture medium comprising GT1b for at least 3 hours; b) contacting the different batches of induced pluripotent stem cell-derived neurons of step a) with a neurotoxin polypeptide; c) cultivating the different batches of induced pluripotent stem cell-derived neurons of step b) for at least 24 hours in the presence of GT1b under conditions which allow for the neurotoxin polypeptide to exert its biological activity, thereby standardizing the sensitivity of the induced pluripotent stem cell-derived neurons to a neurotoxin polypeptide. The invention further relates to a method for the generation of induced pluripotent stem cell-derived neurons having a standardized sensitivity to a neurotoxin polypeptide, comprising the steps of: a) providing different batches of induced pluripotent stem cell-derived neurons; b) cultivating the different batches of induced pluripotent stem cell-derived neurons of step a) in a cell culture medium comprising GT1b for at least 3 hours, thereby standardizing the sensitivity of the induced pluripotent stem cell-derived neurons to a neurotoxin polypeptide. In addition, encompassed by the present invention is a method for determining the biological activity of a neurotoxin polypeptide, comprising the steps of: a) cultivating induced pluripotent stem cell-derived neurons in a cell culture medium comprising GT1b for at least 3 hours; b) contacting the induced pluripotent stem cell-derived neurons of step a) with a neurotoxin polypeptide; c) cultivating the induced pluripotent stem cell-derived neurons of step b) for at least 24 hours in the presence of GT1b under conditions which allow for the neurotoxin polypeptide to exert its biological activity; and d) determining the biological activity of the neurotoxin polypeptide in said cells. Finally, the invention relates to the use of GT1b for a) standardizing the sensitivity of different batches of induced pluripotent stem cell-derived neurons to a neurotoxin polypeptide; or b) reducing the variability of the sensitivity of different batches of induced pluripotent stem cell-derived neurons to a neurotoxin polypeptide.
Inventor(s):	Karl-Heinz Eisele
Assignee:	Merz Pharma GmbH and Co KGaA
Application Number:	US15/119,553

Details for Patent 10,921,312

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Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Merz Pharmaceuticals Gmbh C/o Merz Pharmaceuticals Llc	XEOMIN	incobotulinumtoxina	For Injection	125360	July 30, 2010	10,921,312	2035-02-18
Merz Pharmaceuticals Gmbh C/o Merz Pharmaceuticals Llc	XEOMIN	incobotulinumtoxina	For Injection	125360	November 20, 2015	10,921,312	2035-02-18
>Applicant	>Tradename	>Biologic Ingredient	>Dosage Form	>BLA	>Approval Date	>Patent No.	>Expiredate

International Patent Family for US Patent 10,921,312

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Country	Patent Number	Estimated Expiration
World Intellectual Property Organization (WIPO)	2015124618	⤷ Start Trial
United States of America	2017059558	⤷ Start Trial
Singapore	11201606810S	⤷ Start Trial
Russian Federation	2694191	⤷ Start Trial
Russian Federation	2016131408	⤷ Start Trial
Mexico	377115	⤷ Start Trial
Mexico	2016010144	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration

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