Endotoxins from a Pharmacopoeial Point of View

Franco, Elvira; García-Recio, Verónica; Jiménez, Pilar; Garrosa, Manuel; Girbés, Tomás; Córdoba-Díaz, Manuel; Córdoba-Díaz, Damián

doi:10.3390/toxins10080331

Cited by 32 publications

(21 citation statements)

References 18 publications

(16 reference statements)

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“…Some of these toxins are used in a medical context such as Botox; however, an unintended ingestion is likely to cause health issues ranging from fever to death. [ 1,45,117 ]…”

Section: Thermal Sterilizationmentioning

confidence: 99%

Sterilization of Objects, Products, and Packaging Surfaces and Their Characterization in Different Fields of Industry: The Status in 2020

Jildeh

Wagner

Schöning

2021

Physica Status Solidi (a)

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The treatment method to deactivate viable microorganisms from objects or products is termed sterilization. There are multiple forms of sterilization, each intended to be applied for a specific target, which depends on—but not limited to—the thermal, physical, and chemical stability of that target. Herein, an overview on the currently used sterilization processes in the global market is provided. Different sterilization techniques are grouped under a category that describes the method of treatment: radiation (gamma, electron beam, X‐ray, and ultraviolet), thermal (dry and moist heat), and chemical (ethylene oxide, ozone, chlorine dioxide, and hydrogen peroxide). For each sterilization process, the typical process parameters as defined by regulations and the mode of antimicrobial activity are summarized. Finally, the recommended microorganisms that are used as biological indicators to validate sterilization processes in accordance with the rules that are established by various regulatory agencies are summarized.

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“…Some of these toxins are used in a medical context such as Botox; however, an unintended ingestion is likely to cause health issues ranging from fever to death. [ 1,45,117 ]…”

Section: Thermal Sterilizationmentioning

confidence: 99%

Sterilization of Objects, Products, and Packaging Surfaces and Their Characterization in Different Fields of Industry: The Status in 2020

Jildeh

Wagner

Schöning

2021

Physica Status Solidi (a)

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“…Over the last few decades, the detection methods of LPS have been continuously developed. Previous methods, such as the rabbit pyrogen test (RPT) [ 91 ], the Limulus amoebocyte lysate (LAL) [ 92 ], the monocyte activation test (MAT) [ 93 ], the recombinant factor C (rFC) [ 94 ], and the EndoLISA [ 95 ], cannot be routinely used to analyze clinical sepsis samples because of their disadvantages of temperature dependence, high cost, inconsistent, and long testing time. However, studies have shown that the LPS test methods based on aptamers were used for the early diagnosis of sepsis in the past few years, which have the advantages of sensitivity, specificity, high affinity, low cost, and time-saving.…”

Section: Aptamer-based Detection Of Sepsis-related Biomarkersmentioning

confidence: 99%

Aptamer-based biosensors for the diagnosis of sepsis

Liu

Han

et al. 2021

J Nanobiotechnol

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Sepsis, the syndrome of infection complicated by acute organ dysfunction, is a serious and growing global problem, which not only leads to enormous economic losses but also becomes one of the leading causes of mortality in the intensive care unit. The detection of sepsis-related pathogens and biomarkers in the early stage plays a critical role in selecting appropriate antibiotics or other drugs, thereby preventing the emergence of dangerous phases and saving human lives. There are numerous demerits in conventional detection strategies, such as high cost, low efficiency, as well as lacking of sensitivity and selectivity. Recently, the aptamer-based biosensor is an emerging strategy for reasonable sepsis diagnosis because of its accessibility, rapidity, and stability. In this review, we first introduce the screening of suitable aptamer. Further, recent advances of aptamer-based biosensors in the detection of bacteria and biomarkers for the diagnosis of sepsis are summarized. Finally, the review proposes a brief forecast of challenges and future directions with highly promising aptamer-based biosensors.

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“…Pyrogen test measuring the increase of temperature in rabbits after intravenous injection of sterile tested solution [42,43].…”

Section: Rabbit Pyrogen Test (Rpt)mentioning

confidence: 99%

An expert review on current approaches for endotoxin detection in various biological products

Elkhateeb

Elkhatib

Aboulwafa

2019

Archives of Pharmaceutical Sciences Ain Shams University

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End toxin is heat-stable lip polysaccharide (LPS) present in the outer membrane of the cell wall of Gramnegative bacteria. All parenteral preparations, as well as tissue implants, must be with no pyrogenic level of endotoxin or other related materials because of their associated health hazards and serious clinical effects. Accordingly, detection and limiting endotoxin in various pharmaceutical and biological products represent crucial issues. Rabbit pyrogen test (RPT) and Limulus Amebocyte Lysate (LAL) test are two methods used for endotoxin detection and quantification. Endotoxin detection is one of the most critical quality control tests required by the Food and Drug Administration (FDA) for all parenteral drugs in their final stage. Both in vitro LAL test and in vivo RPT can complement and reinforce each other but in certain cases, they are not interchangeable and they together provide a comprehensive picture of any potential contamination whether by endotoxin or any other pyrogenic matters.

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Endotoxins from a Pharmacopoeial Point of View

Cited by 32 publications

References 18 publications

Sterilization of Objects, Products, and Packaging Surfaces and Their Characterization in Different Fields of Industry: The Status in 2020

Sterilization of Objects, Products, and Packaging Surfaces and Their Characterization in Different Fields of Industry: The Status in 2020

Aptamer-based biosensors for the diagnosis of sepsis

An expert review on current approaches for endotoxin detection in various biological products

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