Sr. Advisor Eli Lilly and Company Indianapolis, Indiana
Regulatory agencies set strict guidelines for the number of visible (generally larger than 100 um) and subvisible particles (generally 2 - 100 um) that can be present in an injectable biologic. The submicron range ( < 2um) is an analytically-challenging population and a significant gap in many pharmaceutical development workflows. Recently, the IQ consortium organized a multi-company assessment of submicron particle levels in 52 unique clinical and commercial products to understand measurement variability and the range of safe and acceptable submicron particle levels. The assessment concluded that, in their current states, submicron measurements should be used for information purposes and not release or quality assurance. This presentation will also describe existing and recently developed technologies for measuring submicron particles, and the remaining analytical gaps.
Learning Objectives:
Describe the safety risks that submicron particles pose to injectable biologics.
Describe the current state of analytical technology for monitoring submicron particles in biologics.
Describe the remaining gaps in understanding the risks of and analytical techniques for monitoring submicron particles in biologics.