Low Endotoxin Recovery - Where does the industry stand?
Low Endotoxin Recovery (LER) Also Known As low Lipopolysaccharide Recovery (LLR) has-been a controversial topic circulating endotoxin testing Throughout The community for Nearly three years. There is some evidence to show LER That is an irreversible masking effect Brought about the combination of some surfactants (Polysorbate) and chelators (Citrate Phosphate) That are used in over 70% of drug formulations, PARTICULARLY biologics.
Although Some-have Suggested "demasking" as a means clustering to Overcome LER and comply-with the US Food and Drug Administration's request for hold-time studies in Biologics License Applications (BLA), Many Are still try trying to Understand whether thesis processes are Actually Necessary. The argument remains que la LER phenomenon is something That Actually HAS-been around for years, and Does not pose a public health risk. While others still questions whether There Is a missing link entre les unrecoverable endotoxin and Its potential to Become active in the human body.
Like most manufacturers endotoxin test, Lonza HAS aussi beens Following The LER movement and is working diligently to find a solution to assist drug manufacturers In Their product investigations. This presentation Will walk through the current status of LER, From Both the user and Regulatory Perspective. We Will give insight as to what regulators are looking to see in the BLA Regarding hold-time studies, as well as Provide insight into what the industry is doing to "unmask" the endotoxin That May be lurking in drug products.