By Anna Rose Welch, editor, Biosimilar Development
Though the IDN is a unique setting of care, there were still several lines of discussion that arose from Kaiser Permanente's best practices that sparked discussion on how other stakeholders, particularly employers, can start to chip away at the systemic issues standing in biosimilars’ way.
At the behest of Congress, an interagency Drug Shortage Task Force, led by the FDA, recently published the Drug Shortages: Root Causes and Potential Solutions report. Here, we unpack the four root causes for drug shortages as determined by the task force.
The transfer of mAb production processes between scales, referred to as scale-up or scale-down, is difficult. This study reviews moving mAb production from a microscale bioreactor to a single-use platform.