Comparison of LAL and recombinant Factor C endotoxin testing assays in human vaccines with complex matrices

M Marius, F Vacher, T Bonnevay - PDA Journal of Pharmaceutical …, 2020 - journal.pda.org
Endotoxins, heat-stable lipopolysaccharides from Gram-negative bacteria, are potential
contaminants that can be introduced during manufacturing of pharmaceutical products …

Comparison of limulus amoebocyte lysate and recombinant factor C assays for endotoxin detection in four human vaccines with complex matrices

M Marius, F Vacher, T Bonnevay - PDA Journal of Pharmaceutical …, 2020 - journal.pda.org
Endotoxins, heat-stable lipopolysaccharides from Gram-negative bacteria, are potential
contaminants that can be introduced during manufacturing of pharmaceutical products …

Collaborative Study of Bacterial Endotoxins Test Using Recombinant Factor C-Based Procedure for Detection of Lipopolysaccharides (Part 3)

Y KIKUCHI, M MUROI, Y NAKAGAWA… - … and Medical Device …, 2023 - jstage.jst.go.jp
Two new recombinant cascade reagents (rCRs), PyroSmart NextGen® and PYROSTAR TM
Neo, have recently become available for endotoxin testing of parenteral drugs in the …

[HTML][HTML] A Study on the Application of Recombinant Factor C (rFC) Assay Using Biopharmaceuticals

DH Kang, SY Yun, SY Eum, KE Yoon, SR Ryu, C Lee… - Microorganisms, 2024 - mdpi.com
Gram-negative bacterial endotoxins can cause pathophysiological effects such as high fever
when introduced into the bloodstream. Therefore, endotoxin testing is necessary when …

[HTML][HTML] Comparison of LAL and rFC Assays—Participation in a Proficiency Test Program between 2014 and 2019

M Piehler, R Roeder, S Blessing, J Reich - Microorganisms, 2020 - mdpi.com
Endotoxin (lipopolysaccharide) testing of drugs is routinely required in pharmaceutical
industries. Suitable compendial assays are defined by national pharmacopoeias. At this …

Endotoxin Detection – from Limulus Amebocyte Lysate to Recombinant Factor C

JL Ding, B Ho - Endotoxins: structure, function and recognition, 2010 - Springer
Gram negative bacterial endotoxin is a biological pyrogen that causes fever when
introduced intravenously. The endotoxin, also known as lipopolysaccharide (LPS), is found …

Genetic engineering approach to develop next-generation reagents for endotoxin quantification

H Mizumura, N Ogura, J Aketagawa… - Innate …, 2017 - journals.sagepub.com
The bacterial endotoxin test, which uses amebocyte lysate reagents of horseshoe crab
origin, is a sensitive, reproducible and simple assay to measure endotoxin concentration. To …

A new era in pyrogen testing

JL Ding, B Ho - TRENDS in Biotechnology, 2001 - cell.com
Pyrogens are substances (usually of biological origin) that cause fever after injection. The
best-studied pyrogen is lipopolysaccharide (LPS, also known as endotoxin), found in the …

Comparison of Limulus amebocyte lysate test methods for endotoxin measurement in protein solutions

L Chen, N Mozier - Journal of pharmaceutical and biomedical analysis, 2013 - Elsevier
The measurement of low levels of bacterial lipopolysaccharides (endotoxins) in protein
samples can be a challenge due to potential interference from the inherent properties of the …

[HTML][HTML] Evaluation of limulus amebocyte lysate and recombinant endotoxin alternative assays for an assessment of endotoxin detection specificity

J Dubczak, N Reid, M Tsuchiya - European Journal of Pharmaceutical …, 2021 - Elsevier
Abstract The United States Pharmacopeia (USP), European Pharmacopeia (EP), and
Parenteral Drug Association (PDA) provide guidance on the validation of alternative …