As new modalities are being developed for cancer therapies, formulation and process development considerations are becoming increasingly complex. For example, strategies from monoclonal antibody ( mAb ) formulation and processing cannot be directly employed to other modalities due to the molecular characteristics and analytical characterization considerations. This symposium will focus on formulation, process and key chemistry, manufacturing, and controls issues of new and upcoming modalities in addition to highlighting the key aspects of a commercialized mAb products. The intent of the session is to provide an overview of various modalities, highlighting critical issues during development through various case studies.

 9:40 a.m. – 12:00 p.m., Nov 15, Ballroom 20D