Pharmaleads for botulinum detection and toxin assay

PHARMALEADS AND THE FDA REQUIREMENTS:

PHARMALEADS assays fulfill the major requirements of the desirable chart expressed by the FDA in its regulatory perspective for non- animal based assays:

suitable for routine commercial use   serotype specific   able to evaluate the enzymatic activity   sensitive to changes in product quality

quantifies BoNT product potency in a range used in human therapeutics   reduces animal testing   results can be expressed in potency   variability: less than 10%,

Reaching sensitivity below 1U and assessing the binding, internalisation, and translocation activities of the BoNTs are the remaining challenges PHARMALEADS is taking up to fulfill all the FDA requirements.