Ipsen Biopharm Limited

Ipsen Developments Limited

Andrew Martin Pickett

Robin Andrew Quirk

Richard Melville France

Lisa Anne Riccalton-Banks

The invention relates to a method for determining the quantity of pre-synaptic neuromuscular blocking substance (notably botulinum toxin) contained in a sample. In one aspects, the method comprises the following steps: (i) determining the minimum voltage Vneeded to induce the contraction of muscle tissue, said muscle tissue being connected to an electrical stimulator through a motor nerve and preferably immersed in an oxygenated physiological buffer containing glucose; (ii) adding the sample containing the pre-synaptic neuromuscular blocking substance; (iii) electrically stimulating, at a voltage at least equal to V, the muscle tissue at certain time intervals; (iv) comparing the effect induced by the sample to the effect induced by a reference substance and thereby determining the quantity of the pre-synaptic neuromuscular blocking substance in the sample.

Quantification of botulinum toxin

The present invention relates to a method for determining the selectivity of a pre-synaptic neuromuscular blocking substance for striated muscle or smooth muscle. The method comprises measuring the effect induced by a pre-determined quantity of pre-synaptic neuromuscular blocking substance upon electrically stimulating striated muscle tissue, measuring the effect induced by a pre-determined quantity of a pre-synaptic neuromuscular blocking substance upon electrically stimulating smooth muscle tissue, and calculating a quotient of the results obtained in order to determine the selectivity of the pre-synaptic neuromuscular blocking substance for striated muscle or for smooth muscle.

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Berkshire, United Kingdom

Andrew Martin Pickett