To establish homogeneity and assign reference values, ten vials were analyzed from each of lot 14HB-D-001, 14HB-D-002, and 14HB-D-003 for a total of thirty vials (no intra-vial replicates). Thaw/freeze stability with respect to concentration was assessed using vials from lot 14HB-D-001 that had undergone 1 or 5 thaw/freeze cycles at either −80 °C or −20 °C, for a total of four (4) vials. The zero time point and three vials from the 1, 7, and 28 day time points were evaluated from each accelerated stability temperature (4 °C, room temperature, and 40 °C).