Did you know that subvisible particles (SVPs) are the leading cause of drug product recalls? These tiny particles are often missed when relying on light obscuration (LO) for particle analysis due to its transparent nature and cannot be detected with LO. These nearly invisible particles can lead to deadly immunogenic responses to patients if not caught correctly.
One infamous example is Omontys (Preginesatide), a drug developed by Affymax. Osmontys was pulled from the shelves due to the tragic deaths of seven patients, ultimately leading to Affymax being completely dissolved.
Download our case study to understand how failing to correctly identify these particles puts patients’ lives and therapeutic developers at risk.