β-glucan As A Process-Related Impurity In Biopharmaceuticals

By Soonbin Kwon, Lalit Saxena, Robert Andersson, Jookyung Lee, Jacqueline Lee, and Dongkyu Shin

Control strategies to identify and mitigate quality and safety risks

Limiting impurities in biopharmaceutical products is critical to patient safety. One such process-related source of impurities – β-glucan – is problematic for drug manufacturers in several ways. In this whitepaper, we dig deeper into the sources of this impurity, its influence on manufacturing and patient safety, and ways to detect and control its amounts in the finished drug product.

β-glucans – a group of naturally occurring β-Dglucose polysaccharides – are troublesome impurities in biopharmaceutical drug products. Mostly introduced through raw materials during manufacturing, high amounts of β-glucans in drug products can elicit an immune response in patients, as well as cause false-positive results by interfering with the compendial Limulus Amebocyte Lysate (LAL) endotoxin test.