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Detection and Measurement of Botulinum Neurotoxin

Request for Data and Information on Technologies

NICEATM requests available data and information on approaches and/or technologies currently used to detect and measure botulinum neurotoxin (BoNT). Submitted information will be used to assess the state of the science and determine technical needs for non-animal test methods that are used to detect the presence of BoNT and measure potency of BoNT preparations.

Federal Register notice announcing data request (June 13, 2018) – View as a webpage

Tests to detect and measure BoNT are required by multiple federal agencies for regulatory and other decision contexts.  Currently, the standard test for these endpoints is a mouse lethality assay that can use large numbers of animals. NICEATM fosters the evaluation and promotion of alternative test methods for regulatory use.  As part of this activity, NICEATM supports efforts to develop, validate, and implement alternative approaches for biologics tests, including those used to detect the presence of BoNT and measure potency of BoNT preparations.

Respondents should provide information on any activities relevant to the development or validation of alternatives to in vivo test methods currently used by federal agencies for regulatory and other decision contexts.  NICEATM also requests available data from in vivo BoNT tests used for similar applications as the proposed alternative, such as distinguishing between BoNT serotypes in biological matrix samples or measuring the potency of therapeutic BoNT preparations. View guidelines for submission of data to NICEATM

Respondents to this request for information should include their name, affiliation (if applicable), mailing address, telephone, email, and sponsoring organization (if any) with their communications.   Responses to this notice will be posted on this page, therefore no proprietary, classified, confidential, or sensitive information should be included in responses. Persons submitting responses will be identified on the web page by name and affiliation or sponsoring organization, if applicable. View NTP guidelines for public comments

Responses Received to the June 2018 Data Request

Workshop on Alternatives to the Mouse LD50 Assay for Botulinum Toxin Testing (2006)

In collaboration with international partners, NICEATM and ICCVAM sponsored a workshop to review methods proposed to replace, reduce, and refine the use of mice for BoNT testing. The workshop identified priorities for research, development, and validation efforts. These efforts are needed to advance the use of alternative methods. A report of the workshop was published in 2008. 

A cell-based assay method discussed at the workshop was later accepted by the FDA (2011) for stability and potency testing of BoNT type A products.