A Validation of the Equivalence of the Cell-Based Potency Assay Method with a Mouse LD₅₀ Bioassay for the Potency Testing of OnabotulinumtoxinA.

ABSTRACT: (1) Background: At present, the only potency assay approved in China for the in-country testing of botulinum toxin type A for injection products is the mouse bioassay (MBA). The Chinese market for neurotoxin products is rapidly expanding, but MBAs are subject to high variability due to individual variations in mice, as well as variations in injection sites, in addition to the limited number of batches tested for one MBA. Compared with the mLD₅₀ method, the cell-based potency assay (CBPA) developed for the potency testing of onabotulinumtoxinA (BOTOX) by AbbVie not only does not use any experimental animals but also allows for significant time and cost savings. Due to the significant benefits conferred by the replacement of the mLD₅₀ assay with CBPA in China, the CBPA

SUBMITTER: Yang Y 

PROVIDER: S-EPMC11209372 | biostudies-literature | 2024 Jun

REPOSITORIES: biostudies-literature