Traditional BET suitability (spike recovery at time zero) is not enough . TR-82 mandates time-dependent recovery studies to detect LER.
Based on PDA TR 82, here is how a Quality Control laboratory should implement a program today. pda technical report 82
This report provides a science-based framework for understanding, detecting, and mitigating Low Endotoxin Recovery (LER)—a masking effect that can prevent the reliable detection of endotoxins in biologics. Traditional BET suitability (spike recovery at time zero)
TR 82 is structured to guide a manufacturer from basic theory to actionable practice. Below is a breakdown of its seven major sections. pda technical report 82