In Vitro Test Methods for Detection and Quantification of Botulinum Neurotoxins and Detection of Non-Endotoxin Pyrogens

On May 23,  the US Health and Human Services Department published a data request about "Nomination of In Vitro Test Methods for Detection and Quantification of Botulinum Neurotoxins and Detection of Non-Endotoxin Pyrogens -  for Substances Evaluated by these Test Methods". Comments can be submitted until o7 July 2011.

On behalf of the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM), the NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) requests public comments on nominations received for  the three in vitro test methods proposed for detecting and quantifying botulinum neurotoxin (BoNT), and at second for an in vitro test method proposed for detecting non-endotoxin pyrogens.

They seek data generated through alternative test methods for detecting and quantifying BoNT, including but not limited to three test methods nominated by BioSentinel Pharmaceuticals, Inc. (BioSentinel). Data from the standardized mouse LD 50 assay currently used for these endpoints are requested for comparison. In addition, the department is looking for data generated through alternative test methods for identifying non-endotoxin pyrogens, including but not limited to the monocyte activation test (MAT), which was nominated by Biotest AG. Data on non-endotoxin pyrogens tested in the rabbit pyrogen test (RPT) are requested for comparison. NICEATM received nominations for validation studies on each of the above test methods, which have the potential to reduce or replace animal use for regulatory testing. At this time, ICCVAM requests public comments on the appropriateness and relative priority of these activities.

The complete document can be found here.

Please pay attention to ECA's course about "Endotoxin and Pyrogen Testing", 28 and 29 June 2011 in Heidelberg. Experts from research and industry provide you with information about the different tests, their implementation, regulatory background and the latest developments in these fields.

Author:
Axel H. Schroeder
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)

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