The technical report breaks down the choice between active and passive transport technologies:
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Surfactants (e.g., polysorbate 80) or proteins in biopharmaceuticals can encapsulate endotoxin molecules into micelles. The LAL enzyme cannot access the lipid A, producing a false negative. The technical report breaks down the choice between
PDA Technical Report No. 82: Low Endotoxin Recovery (TR 82) is a 128-page guidance document published in March 2019 that addresses the phenomenon of endotoxin masking in biologics. Parenteral Drug Association Where to Obtain the Paper As a copyrighted publication of the Parenteral Drug Association (PDA) pda technical report 82 pdf