Figure 5. Evaluation of freeze-thaw stability of the formulated MS-Hu6 (100 mg/mL) at −80/25 °C and –80 °C/37 °C for three cycles.

(A) Samples were analyzed using protein thermal shift for thermostability. After storage at −80/25 °C, ΔT_m values for both Fc and Fab domains revealed no significant difference between each cycle and baseline. However, for samples stored at –80 °C/37 °C (three cycles), while the Fc domain remained stable, there was a small change in Fab ΔT_m (within acceptable limit of 1 °C). (B) Samples were also analyzed using dynamic light scattering (DLS) for colloidal stability. The major peak (Peak 1) hydrodynamic radius (rh) was found to be between 3 and 7 nm at both storage conditions (−80/25 °C and –80 °C/37 °C). PDI—polydispersity index. The data suggest no or minimal reversible aggregation (<0.5%; acceptable limit: 5–10%).