By Dr. Bhushan Munjal, Ph.D.
The overall product attributes of a lyophilized protein formulation are governed by the phase behavior of individual formulation components during the freezing and drying steps of the lyophilization process.
The freezing process exert multiple stresses that can destabilize the active protein. As a result, protein formulations often contain multiple excipients to obtain the desired product attributes.
As a result, protein formulations often contain multiple excipients to obtain the desired product attributes. The phase behavior of excipients is often affected by the presence of other components in the formulation and this can have an effect on the product performance.
A recent webinar described the complex effects of combining excipients in a formulation and the importance of determining optimal concentrations and processing conditions for lyophilization of protein formulations.