The botulinum toxin LD50 potency assay - another chapter, another mystery.

Alternatives to the LD50 assay for botulinum toxin potency testing: Strategies and progress towards refinement, reduction and replacement

Therapeutic preparations of botulinum toxin products are calibrated by a mouse LD50 assay, and the labelled unit of activity is expressed in mouse LD50 units, defined as the median lethal intraperitoneal dose at a defined time-point. Potency and stability testing are required at several stages of the production process. Testing at the final lot stage requires high precision, so a large number o...

Test Method Nomination to the ICCVAM Nomination of Alternative Methods to Replace the Mouse LD50 Assay for Botulinum Toxin Potency Testing

Spinal cord--skeletal muscle cocultures detect muscle-relaxant action of botulinum neurotoxin A.

The mouse LD50 assay is routinely used for potency testing of botulinum toxins. Unfortunately, this test is associated with severe pain and distress in animals and requires large quantities of mice. Here we used cocultures of spinal cord and muscle tissue as an alternative for probing botulinum toxins. Cocultures were prepared from mouse embryonic tissue (C57/BL6J) and cultured for 24-27 days. ...

Spinal cord - skeletal muscle cocultures detect muscle - relaxant action of botulinum neurotoxin A 1

The mouse LD50 assay is routinely used for potency testing of botulinum toxins. Unfortunately, this test is associated with severe pain and distress in animals and requires large quantities of mice. Here we used cocultures of spinal cord and muscle tissue as an alternative for probing botulinum toxins. Cocultures were prepared from mouse embryonic tissue (C57/BL6J) and cultured for 24-27 days. ...

The current scientific and legal status of alternative methods to the LD50 test for botulinum neurotoxin potency testing. The report and recommendations of a ZEBET Expert Meeting.

An Expert Meeting on The Current Scientific and Legal Status of Alternative Methods to the LD50 Test for Botulinum Neurotoxin (BoNT) Potency Testing was organised by the Centre for Documentation and Evaluation of Alternatives to Animal Experiments (ZEBET) at the Federal Institute for Risk Assessment (BfR), and took place on 27–28 April 2009, in Berlin, Germany. The goal of ZEBET is to promote p...