GMP Potency Testing of Botulinum Products

We are currently preparing for the EU marketing authorisation (MAA) submission of a product containing Botulinum Toxin Type A, which is identical in active substance to Botox and similar products. Our current validated method utilizes in vivo mouse assays (LD50) for potency testing as part of product specification. We are developing and validating a cell-based potency method, which will not be fully implemented before our upcoming MAA submission. We intend to transition to the cell-based assay in accordance with regulatory commitments at a later stage. In this context, we are seeking information on whether your organization:

– Currently performs mouse-based potency testing for botulinum toxin products under GMP conditions, or

– Can recommend or facilitate access to a GMP-certified testing facility in Europe that provides this service.

We would greatly appreciate any information or support you can provide regarding this matter, and we hope to receive positive news from your team soon.

Thank you for your time and consideration.