Ipsen Pharma has received approvals from U.S. and Canadian regulatory authorities for use of their in vitro Cell-Based Assay to establish stability and potency of its botulinum toxin products. This follows prior approval received in the European Union and Switzerland for this application of the Cell-Based Assay.
The basis of the Cell-Based Assay is the BoCell® technology platform, developed by BioSentinel Inc., a Madison, Wisconsin-based company that specializes in developing platforms for the detection and measurement of botulinum toxins. BioSentinel and Ipsen collaborated closely in development of the Cell-Based Assay, which achieves a level of precision comparable to the mouse-based LD50 assay.
The announcement of the approval is available at https://www.ipsen.com/websites/Ipsen_Online/wp-content/uploads/2019/02/01155324/00-IAW-POSITION-STATEMENT-US-and-CN-approvals-01-02-2019.pdf.