Comparison of bacterial endotoxin testing methods in purified pharmaceutical water matrices

Marius, Marine; Vacher, Frédéric; Bonnevay, Thierry

doi:10.1016/j.biologicals.2020.07.001

Cited by 13 publications

(8 citation statements)

References 4 publications

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“…The second study in 2020 from Marius et al and the team at Sanofi Pasteur compared two different LAL methods (kinetic chromogenic and cartridge) and one rFC method and their ability to detect and quantify endotoxins in 20 different purified water samples including water for injection, purified water and cleaning validation samples [64]. The results demonstrated that the two most appropriate methods for rapid endotoxin detection in water are LAL and rFC, though not the investigated LAL cartridge technology.…”

Section: Comparison Of Bacterial Endotoxin Testing Methods In Purified Pharmaceutical Water Matricesmentioning

confidence: 99%

Corrigendum

2021

BioTechniques

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Testing of parenteral pharmaceuticals and medical devices for pyrogens (fever-inducing substances) is critical to patient safety. The original rabbit pyrogen test has largely been replaced by different bacterial endotoxin tests based on Limulus amebocyte lysate (LAL), sourced from the blood equivalent of horseshoe crabs after comparative studies to the rabbit pyrogen test. Since 2004 a bacterial endotoxin test based on recombinant factor C (rFC), the endotoxin sensor protein inside of LAL, has been used as an animal-free alternative to LAL. Likewise, numerous studies compared LAL and rFC. Here we describe the history of pyrogen and bacterial endotoxin testing and summarize the evidence presented by those studies. We demonstrate that rFC and LAL are equivalent and comparable.

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Section: Comparison Of Bacterial Endotoxin Testing Methods In Purified Pharmaceutical Water Matricesmentioning

confidence: 99%

Corrigendum

2021

BioTechniques

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“…The limulus amebocyte lysate (LAL) test is the gold standard for LPS detection. It is used to detect LPS contamination in parenteral drugs, clinical samples, medical equipment, and water for injection (WFI). , Although this test has high sensitivity, it is time-consuming, taking up to 2 h. − Moreover, the LAL test has to be performed manually, and the samples have to be shipped in to a laboratory from collection sites because clean technology is required for accurate analysis, and it requires an expensive photometer with specialized software. , These circumstances result in delays in decision-making at clinical or drug manufacturing sites. Although alternatives to the LAL test have been developed, none has been used practically because of inconvenience issues, such as time-consuming procedures .…”

Section: Introductionmentioning

confidence: 99%

High-Throughput Analysis of Bacterial Toxic Lipopolysaccharide in Water by Dual-Wavelength Monitoring Using a Ratiometric Fluorescent Chemosensor

Kimoto,

Takahashi,

Masuko

et al. 2023

Anal. Chem.

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Lipopolysaccharide (LPS) is a bacterial toxin that causes fever in humans. Our small-molecule chemosensor named Zn-dpa-C2OPy shows rapid ratiometric fluorescence response to LPS in water with a detection limit of 11 pM, which is lower than that of our previously reported sensor. Spectroscopic measurements (fluorescence, absorbance, 1 H NMR, and fluorescence lifetime), dynamic light scattering measurements, and transmission electron microscopy observations revealed that the fluorescence response was induced by the changes in the aggregation state via multi-point recognition of LPS through hydrophobic and electrostatic interactions, in addition to the coordination between the zinc(II)-dipicolylamine moiety of the chemosensor and the phosphate group of LPS. The proposed Zn-dpa-C2OPy chemosensor was applied to an original flow injection analysis (FIA) system with a self-developed dual-wavelength fluorophotometer, and a high throughput of 36 samples per hour was achieved. These results demonstrate the feasibility of this unique methodology combining a ratiometric fluorescent chemosensor and FIA for continuous online monitoring of LPS in water.

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“…Many studies have found that the recombinant reagents have very similar characteristics to lysate reagents. [21][22][23][24][25][26][27][28][29] However, one research study in Japan found that unlike lysate reagents, both rFC reagents had almost no reactivity, whereas PyroSmart ® had slight reactivity to endotoxin from Helicobacter Pylori GU2. 29) Another study found that both rFC reagents could not detect endotoxin added to Heparin Calcium even when diluted to the maximum valid dilution (MVD).…”

Section: Introductionmentioning

confidence: 99%

Advanced Recombinant Cascade Reagent PyroSmart NextGen<sup>®</sup> for Bacterial Endotoxins Test as Described in the Pharmacopeias

Stevens¹,

Ogura

Kelley³

et al. 2022

BPB Reports

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The bacterial endotoxins test (BET) is a method of detection and quantification of bacterial endotoxin in injectable drugs and medical devices using amoebocyte lysate reagents sourced from the horseshoe crab (Limulus polyphemus or Tachypleus tridentatus). Three manufacturers have launched three different types of recombinant reagents, and recently the United States, European and Japanese Pharmacopeias have been evaluating the equivalency of these reagents to natural amoebocyte lysate reagents. Several studies suggested that the recombinant reagents are very similar to amoebocyte lysate reagents, however there is potential for improvement. Previous reports indicate that recombinant reagents have two issues: extremely low endotoxin potency determination for Helicobacter pylori GU2 and high levels of interference from Heparin Calcium impacting endotoxin recovery. A new recombinant cascade reagent (rCR), PyroSmart NextGen ® , recently introduced to the market has been developed to solve these issues. PyroSmart NextGen ® has demonstrated higher reactivity to H. pylori GU2 and a lower level of interference from Heparin Calcium than other existing recombinant reagents. Additionally, the analytical capability and suitability of PyroSmart NextGen ® has been demonstrated when applied to the BET as described in the US, European and Japanese pharmacopeias. PyroSmart NextGen ® has also shown comparability to amoebocyte lysate reagents by demonstrating its ability to detect autochthonous endotoxin in water and in Escherichia coli culture. Overall, this study has verified that the rCR, PyroSmart NextGen ® is a suitable alternative to amoebocyte lysate reagents.

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Comparison of bacterial endotoxin testing methods in purified pharmaceutical water matrices

Cited by 13 publications

References 4 publications

Corrigendum

Corrigendum

High-Throughput Analysis of Bacterial Toxic Lipopolysaccharide in Water by Dual-Wavelength Monitoring Using a Ratiometric Fluorescent Chemosensor

Advanced Recombinant Cascade Reagent PyroSmart NextGen<sup>®</sup> for Bacterial Endotoxins Test as Described in the Pharmacopeias

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