Endotoxins are a highly pyrogenic and immunogenic contaminant of bacterial origin that must be avoided during the manufacturing of biopharmaceutical products to ensure safety and efficacy. Low endotoxin recovery, also known as a masking effect, is defined as the ability to detect
Journal of Chromatography A 1671 (2022) 462995 Contents lists available at ScienceDirect Journal of Chromatography A journal homepage: www.elsevier.com/locate/chroma The impact of endotoxin masking on the removal of endotoxin during manufacturing of a biopharmaceutical drug product Martina Wespel a, Melanie Geiss a, Matthias Nägele a, Stephanie Combé a, Johannes Reich b, Joey Studts a, Jessica Stolzenberger a,∗ a b Boehringer Ingelheim Pharma GmbH & Co KG, Biberach, Germany Microcoat Biotechnologie GmbH, Bernried, Germany a r t i c l e i n f o Article history: Received 14 December 2021 Revised 18 March 2022 Accepted 24 March 2022 Available online 26 March 2022 Keywords: Low endotoxin recovery Endotoxin removal Ion exchange chromatography Ultrafiltration/Diafiltration Bacterial Endotoxin Testing Endotoxin Lipopolysaccharide a b s t r a c t Endotoxins are a highly pyrogenic and immunogenic contaminant of bacterial origin that must be avoided during the manufacturing of biopharmaceutical products to ensure safety and efficacy Low endotoxin recovery, also known as a masking effect, is defined as the ability to detect