Results of a harmonized endotoxin recovery study protocol evaluation by 14 BioPhorum Operations Group (BPOG) member companies.

Significant regulatory and biopharmaceutical manufacturing attention has been recently generated regarding the inability to recover purified lipopolysaccharide in certain biopharmaceutical products, specifically those containing a chelator and surfactant. Disparate data has been generated and submitted during regulatory review. Study design is thought to significantly impact, and cause the confounding data.