Understanding Particles and Their Impact to Biologics and Biosimilars

Particles in an injectable drug product represent a huge risk not only to patient safety &ndash; but also to a drug company&rsquo;s reputation and bottom line. Presence of visible or sub-visible particles has been one of the most common reasons for recalls. According to the <em>FDA Recalls, Market Withdrawals, &amp; Safety Alerts</em> database, 23 of 59 (39%) recalls, market withdrawals, and safety alerts between 2018 and 2020 were due to particulate contamination¹.