Large-Scale Freezing of Biopharmaceutical Drug Product

This application note examines how well the Sartorius Stedim Biotech’ CryoWedge™ models freezing in a large-scale freeze-thaw vessel, or CryoVessel™. A glycine- sucrosephosphate formulation was selected as a representative solution for the freeze-thaw studies. Samples were draw- from the center of the CryoWedge and from the corresponding center of the wedge in the CryoVessel during the freezing process. Samples were subjected to conductivity and pH assays to examine the distribution of solutes.