POSITION STATEMENT TO SUPPORT THE PUBLICATION OF THE PAPER ON THE METHODS FOR BOTULINUM TOXIN TESTING IN THE JOURNAL 'ALTERNATIVES TO LABORATORY ANIMALS'

Ipsen has been working for some time to develop alternative testing methods to the use of the LD50 potency test for botulinum toxin. Dr Donald W. Straughan reviews the progress of these research methods in the June 2006 issue of Alternatives To Laboratory Animals.¹

The LD50 is a long-established standard and licensed method used worldwide for determining the potency of each batch of botulinum toxin. The product must be quality control tested in accordance with the strict requirements of the UK regulatory authorities before being used in patients to treat approved conditions. It is imperative to know the exact potency of each batch of botulinum toxin in order to administer doses that are both safe and effective for the required treatment.

Ipsen is committed to the 'Three Rs' principle of Refinement, Reduction and Replacement of laboratory animals used in the production of botulinum toxin. The Company has made a sustained effort in this area and our research is currently focused on three alternative testing methods; an endopeptidase activity assay, an ex vivo neuromuscular junction (NMJ) assay and an enzyme-linked immunosorbent assay (ELISA). The progress with all three assays is detailed in Dr Straughan's paper.¹

In addition, we seek to reduce the use of animals for toxin testing wherever possible, subject to the regulatory guidelines and requirements. To this end, Ipsen has continued dialogue with the regulatory authorities and their representatives to ensure continued efforts in these areas are focused, especially regarding patient safety.

Ipsen is currently validating the three assays and anticipates that the work will ultimately mark a critical milestone towards the end of the LD50 potency testing used in the manufacture of this product. The results will be presented as soon as possible to the regulatory authorities for consideration.

Reference

1. Straughan, DW. Progress in applying the three Rs to the potency testing of botulinum toxin type A. Alternatives To Laboratory Animals 2006; 34(3):305-313