Three different lyophilized batches for validation of FabRICATOR-based analytical methods. FabRICATOR (IdeS) is an IgG-specific cysteine protease that digests antibodies at a single amino acid site below the hinge, generating homogenous F(ab’)2 and Fc fragments.
The FabRICATOR enzyme has become a widely used tool in the biopharmaceutical industry for characterizing monoclonal antibodies, Fc-fusion proteins, ADCs and biosimilars for therapeutic use.Each batch of the FabRICATOR enzyme is rigorously tested for enzymatic activity, identity and purity before it is released. The FabRICATOR Validation Kit consists of three batches of the lyophilized enzyme, to make the method validation easier. A certificate of analysis is included with each batch.
•Simplified method validation for QC applications
•Ideal format for batch-to-batch variability assessment
•Increased confidence in performance of batch release assays
