Preformulation Assessment for Large Biotherapeutics Enabling Early Understanding of the Clinical Service Formulation

My Name is Shwetha Iyer, and I work as a Principal Scientist I in Novartis. My organization in Novartis is called Novartis Biologics Center (NBC) which is a part of NIBR here in Cambridge, MA. Within NBC, I am leading the formulation team for large biotherapeutics and other modalities such as gene therapy, Adeno-associated virus (AAV), Lentivirus (LV) etc. My group’s core responsibility includes but not limited to establishing developability assessments focusing on preformulation studies for large biotherapeutics in order to successfully lock down clinical service formulation for Phase I studies and in some cases, beyond Phase I. We work with high throughput, state of the art automation systems that enable us to determine the degradation mechanisms of the protein during stability and mitigate the risk to enable a successful liquid in a vial (LiVi) for clinical applications