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AltTox Digest
June 2011



Cell-based Assay for Botox© Potency Developed and Approved

In recent years, one of the most high-profile and controversial areas of animal testing has been the potency testing of products that contain botulinum neurotoxin, such Botox©. The regulatory standard in this field has been the mouse LD50 test, with death by paralysis and suffocation as the endpoint. Over 100,000 animals per year are estimated to be used in this test worldwide. Although botulinum toxin-based products have a growing list of therapeutic uses, their cosmetic application (temporarily smoothing certain facial wrinkles) represents by far the greatest clinical use. It is primarily the large use of animals in LD50 testing for a cosmetic application that has fueled criticism of this testing.

The LD50 potency testing for botulinum-based products has been the subject of an exposé, undercover investigation, a lawsuit, and shareholder resolutions, as well as scientific workshops and expert groups. [Full disclosure: The Humane Society of the United States, which co-manages AltTox, has been an advocate for progress in this arena.] Various efforts at refinement, reduction, and replacement of animal use in this test have been made, with noteworthy successes, but a full replacement method with regulatory approval has proven elusive. Moreover, the companies that market botulinum-based products are not necessarily using the same sub-type of neurotoxin nor using the same reference standard for LD50 testing, so that any one replacement method may not be directly transferable among companies. This has resulted in a fragmentation of 3Rs efforts by the companies involved.

However, a major breakthrough has been achieved. As reported recently in the AltTox Forum during the same weekend that the development was announced publicly, Botox-manufacturer Allergan revealed that the company has developed a cell-based alternative to the mouse LD50 test and has received U.S. Food and Drug Administration approval for the new method. The California-based company will begin using the procedure immediately in the product release phase of the manufacturing process and seeking regulatory approval in its overseas markets. As a result, Allergan expects to reduce its animal use by 95% within 3 years. The company also plans to discuss its new procedure (which is being written up for publication) with other manufacturers of botulinum-based products to see if the method can be tailored to those products. Kudos to Allergan for developing the new procedure, and to the FDA for approving it.

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