High concentration formulations are required for the efficacy of the monoclonal antibodies especially in metabolic disorder treatments and for the comfort of patients subjected to high volume injections.  In one of our therapeutic candidates there is a highly negatively charged amino acid sequence region which we have determined to be the core region which causes extremely high viscosities in formulations above 100 mg/ml.  Using Molecular Modeling, amino acid substitution and empirical screening methods, we have determined that small amounts of divalent cations in our formulations can lower the viscosity by as much as 80% thus allowing high concentration formulation feasible for manufacturing and patient dosing.

Use of divalent cations to mitigate viscosity in monoclonal antibodies

241st National Meeting (2011)

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