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.
- USP Publishes Monoclonal Antibody Guidelines (Pharmtech)
- New USP Standards for Characterization of Therapeutic Proteins
- Journal of Pharmaceutical biomedical analysis; Implementation of USP antibody standard for system suitability in capillary electrophoresis sodium dodecyl sulfate (CE-SDS) for release and stability methods
- The Role of Public Standards in the Development of Biosimilars
- USP Reference Standards for Residual DNA Testing of Recombinant Biotherapeutics