Lyophilization (or freeze-drying) finds extensive application in the development of injectable pharmaceutical proteins. However, this process has a potential to destabilize proteins due to stresses encountered during the freezing and drying phases. As a result, excipients are added each with a designated functionality. These may include a bulking agent, lyoprotectant, buffer, tonicity modifying agent, surfactant and a solubilizer. The presence of multiple excipients makes the formulation complex and enhances the possibility of excipient-excipient and protein-excipient interactions. Such interactions can affect protein stability and excipient functionality. This webinar will review the interplay of different formulation components on the protein stability and excipient functionality in frozen and freeze-dried systems, with relevant case studies. Specifically, the focus is on physical interactions that have the potential to alter the physical state of excipient(s), thereby affecting its functionality. Presented by Dr. Bhushan Munjal, PhD, Postdoctoral Associate, Department of Pharmaceutics at University of Minnesota
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