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- This "phenomenon" has been observed for more than 20 years, but never identified
- Underlying mechanism of action is still unknown
- Primarily affects formulations of polysorbate/citrate buffers
Low Endotoxin Recovery (LER) is a controversial topic that has been circulating throughout the endotoxin detection community for the last two years. This phenomenon is hypothetically described as a “masking effect” manifested in the biophysical formation of a complex that blocks the ability of Factor C, the main component in LAL detection, to bind endotoxin (J. Chen, Low Endotoxin Recovery in Common Biologics Products, presented at the 2013 Annual PDA Meeting, Orlando, FL, April 2013).