Monoclonal Antibody System Suitability Standard


Build consistency and reproducibility into your analytical methods. A common analytical challenge associated with monoclonal antibody products is ascertaining if a specific method can resolve relevant product variants.

The USP monoclonal IgG system suitability standard was developed to address this issue by using a variety of analytical methods confirmed in an international round robin study, and extensive characterization of a monoclonal antibody material at six collaborative labs.

Manufacturers can use this standard to assess the performance of methods that measure molecular variants, purity, and oligosaccharidesfor monoclonal antibody therapeutics.

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