Subcutaneous Trastuzumab Case: Achieving concentration of 250mg/mL at a syringeable viscosity of 18 cP.
Using only 2 GRAS excipients, BRL has achieved concentrations of over 250mg/mL with viscosities less than 20cP. Stability data - both in-house and from third party CROs, shows that this high-concentration, low-viscosity formulation of Trastuzumab is physically, chemically and biologically stable over a six month duration at normal temperatures. PK/PD studies show comparable efficacy to the innovator Trastuzumab. This could potentially result in a low-cost, low-volume, high-concentration, subcutaneous version of Trastuzumab.