The monocyte activation test detects potentiated cytokine release resulting from the synergistic effect of endotoxin and non-endotoxin pyrogens [PDF]
Pyrogens are classified in two groups, endotoxin pyrogens and non-endotoxin pyrogens (NEPs). The presence of either in parenteral pharmaceuticals or medical devices can cause severe harm to subjects, and when occurring in combination, synergistic ...
Shahrzad Timman
exaly +3 more sources
Advancing Pyrogen Testing for Vaccines with Inherent Pyrogenicity: Development of a Novel Reporter Cell-Based Monocyte Activation Test (MAT) [PDF]
Background/Objectives: Pyrogens, fever-inducing substances from biological or environmental sources, are recognized by Toll-like receptors (TLRs) predominantly expressed by human monocytes and represent a critical quality attribute (CQA) for ...
Sijia Yi +5 more
doaj +2 more sources
NOMO-1 cells expressing an NF-κB luciferase reporter gene facilitate a simple, rapid monocyte activation test that can detect a wide range of pyrogens. [PDF]
Pyrogens, which include endotoxin and non-endotoxin pyrogens (NEPs), act on immune cells in the bloodstream, causing various effects such as fever and endotoxic shock. The limulus amebocyte lysate test, a commonly used endotoxin test in the manufacturing
Tomohisa Nanao +6 more
doaj +2 more sources
Evaluation of the effect of cell freshness on pyrogen detection using a serum-free monocyte-activation test. [PDF]
Pyrogens cause shock symptoms when released into the bloodstream. They are classified into two main categories: endotoxins (lipopolysaccharides [LPS]) and non-endotoxin pyrogens.
Katsuhiko Hayashi +8 more
doaj +2 more sources
A novel alternative for pyrogen detection based on a transgenic cell line [PDF]
Pyrogen, often as a contaminant, is a key indicator affecting the safety of almost all parenteral drugs (including biologicals, chemicals, traditional Chinese medicines and medical devices).
Qing He +14 more
doaj +2 more sources
Development of pyrogen-free utensils for cell culture by combining ozone/hydrogen peroxide mixed gas sterilization with steam-washing technology [PDF]
Objective: The aim of this study was to develop disposable cell culture utensils with improved cleanliness. Methods: Pyrogen contamination levels were evaluated using a direct human cell-based pyrogen test (HCPT).
Shaimaa Ibrahim +12 more
doaj +2 more sources
The widely accepted strategy to justify the use of medicinal plant extracts in diseases with inflammatory background is their examination on in vitro models using immune cells.
Aleksandra Kruk +4 more
doaj +1 more source
Phytochemical Screening and Antibacterial Activity of the Ethanolic Stem Bark Extract of Eucalyptus Camaldulensis [PDF]
In this study, the stem bark of Eucalyptus camaldulensis was subjected to preliminary phytochemical and anti-bacterial analysis. The extraction of the stem bark was done with ethanol with a recovery of 12.1 %. The phytochemical evaluation, as well as the
Raymond Iorhemen +2 more
doaj +1 more source
Detection of Pyrogens in Hormonal Implants Using the LAL Test
The State Pharmacopoeia of the Russian Federation, 14th edition states that implants are a sterile dosage form, and have to be tested for pyrogens. However, it does not provide details on how the test should be performed for this dosage form.The aim of ...
N. P. Neugodova +3 more
doaj +1 more source
Validation of moist and dry heat processes used for sterilization and depyrogenation during ampoules manufacturing [PDF]
Pyrogens are fever-producing substances, which are metabolic products of microorganisms and most potent pyrogens are the endotoxins. Depyrogenation can be defined as the elimination of all pyrogenic substances which is an important part of the ...
Ahmed Rashed +3 more
doaj +1 more source

