Factors affecting recovery of endotoxin adsorbed to container surfaces

TJ Novitsky, J Schmidt-Gengenbach… - PDA Journal of …, 1986 - journal.pda.org
A quantitative, sensitive, and reproducible kinetic turbidimetric adaptation of the Limulus
amebocyte lysate (LAL) assay was used to assess endotoxin adsorption/recovery from …

Evidence against a bacterial endotoxin masking effect in biologic drug products by limulus amebocyte lysate detection

JS Bolden, ME Claerbout, MK Miner… - PDA Journal of …, 2014 - journal.pda.org
The inability to detect endotoxin using compendia methods is a potential safety concern for
patients due to the lack of endotoxin removal capabilities at the fill–finish stage in typical …

Quantitation of endotoxin in products using the LAL kinetic turbidimetric assay.

JF Remillard, MC Gould, PF Roslansky… - Progress in Clinical …, 1987 - europepmc.org
The data presented here show the kinetic turbidimetric LAL assay to be a highly quantitative
and effective method for determining endotoxin concentrations in products. The assay …

Endotoxin contamination of parenteral drugs and radiopharmaceuticals as determined by the limulus amebocyte lysate method

CW Twohy, AP Duran, TE Munson - PDA Journal of Pharmaceutical …, 1984 - journal.pda.org
From January 1980 to October 1983, the Food and Drug Administration (FDA) examined
2526 samples, including 333 different drug products, by the limulus amebocyte lysate (LAL) …

Factors affecting reduction of reference endotoxin standard activity caused by chelating agent/detergent matrices: Kinetic analysis of low endotoxin recovery

M Tsuchiya - PDA Journal of Pharmaceutical Science and …, 2017 - journal.pda.org
Reduction of reference standard endotoxin activity was kinetically analyzed under low
endotoxin recovery conditions and was considered as an apparent first-order reaction …

[HTML][HTML] Low endotoxin recovery—Masking of naturally occurring endotoxin

J Reich, FA Weyer, H Tamura, I Nagaoka… - International journal of …, 2019 - mdpi.com
Endotoxins are cell wall components of Gram-negative bacteria. A release of endotoxins into
the human blood stream results in an inflammation reaction that can lead to life-threatening …

Destruction of typical endotoxins by dry heat as determined using LAL assay and pyrogen assay

T Nakata - PDA Journal of Pharmaceutical Science and …, 1993 - journal.pda.org
The kinetics of destruction by dry heat of two typical endotoxins, Escherichia coli 055: B5 (E.
coli endotoxin) and Salmonella abortus equi (S. abortus equi endotoxin), were determined …

[HTML][HTML] Investigation of the kinetics and mechanism of low endotoxin recovery in a matrix for biopharmaceutical drug products

J Reich, H Tamura, I Nagaoka, H Motschmann - Biologicals, 2018 - Elsevier
The inability to detect endotoxin added to undiluted drug samples has been called: Low
Endotoxin Recovery (LER). The phenomenon has caused concerns amongst drug …

Methods of endotoxin removal from biological preparations: a review

POMD Batista, AM Lopes, PG Mazzola, COR Yagui… - 2007 - icts.unb.br
PURPOSE: Endotoxins, also called lipopolysaccharides (LPS), are major contaminants
found in commercially available proteins or biologically active substances, which often …

Comparison of several control standard endotoxins to the National Reference Standard Endotoxin--an HIMA collaborative study

FC Pearson, ME Weary, HE Sargent… - Applied and …, 1985 - Am Soc Microbiol
A collaborative study, initiated under the auspices of the Health Industry Manufacturers
Association (HIMA), was designed to establish the relationship of Escherichia coli O55: B5 …