Evaluation of the bacterial endotoxin test for quantification of endotoxin contamination of porcine vaccines

Ogikubo, Yasuaki; Norimatsu, Mari; Noda, Katsuji; Takahashi, Junkichi; Inotsume, Miho; Tsuchiya, Masaharu; Tsutsumi, Yutaka

doi:10.1016/j.biologicals.2004.05.001

Cited by 24 publications

(17 citation statements)

References 20 publications

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“…The endotoxin concentration of the M-CSF in the same lot we used was determined using the kinetic turbidimetric technique with the endotoxinspecific LAL ES-Test (Wako Pure Chemical Industries). The procedure was previously described (18), and Japanese standard endotoxin, which is a lyophilized preparation of endotoxin extracted from the Escherichia coli UKT-B strain, was used as a standard. The measured endotoxin concentration in the M-CSF was 0.04 endotoxin unit/1 ϫ 10 6 U M-CSF.…”

Section: M-csf Preparationmentioning

confidence: 99%

Macrophage Colony-Stimulating Factor Induces Vascular Endothelial Growth Factor Production in Skeletal Muscle and Promotes Tumor Angiogenesis

Okazaki

Ebihara

Takahashi

et al. 2005

The Journal of Immunology

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Although M-CSF has been used for myelosuppression due to chemotherapy in patients with solid tumors, the effect of exogenous M-CSF on tumor angiogenesis has not been studied. In this study we showed that M-CSF has the ability to accelerate solid tumor growth by enhancing angiogenesis with a novel mechanism. M-CSF accelerated intratumoral vessel density in tumors inoculated into mice, although it did not accelerate the proliferation of malignant cells and cultured endothelial cells in vitro. In both the absence and the presence of tumors, M-CSF significantly increased the circulating cells that displayed phenotypic characteristics of endothelial progenitor cells in mice. Moreover, M-CSF treatment induced the systemic elevation of vascular endothelial growth factor (VEGF). VEGFR-2 kinase inhibitor significantly impaired the effect of M-CSF on tumor growth. In vivo, M-CSF increased VEGF mRNA expression in skeletal muscles. Even after treatment with carageenan and anti-CD11b mAb in mice, M-CSF increased VEGF production in skeletal muscles, suggesting that systemic VEGF elevation was attributed to skeletal muscle VEGF production. In vitro, M-CSF increased VEGF production and activated the Akt signaling pathway in C2C12 myotubes. These results suggest that M-CSF promotes tumor growth by increasing endothelial progenitor cells and activating angiogenesis, and the effects of M-CSF are largely based on the induction of systemic VEGF from skeletal muscles.

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Section: M-csf Preparationmentioning

confidence: 99%

Macrophage Colony-Stimulating Factor Induces Vascular Endothelial Growth Factor Production in Skeletal Muscle and Promotes Tumor Angiogenesis

Okazaki

Ebihara

Takahashi

et al. 2005

The Journal of Immunology

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“…The release of LPS occurs not only upon cell death but also during growth and division. In the pharmaceutical industry, it is essential to remove endotoxins from parenteral preparations since they have multiple injurious biological activities, including pyrogenicity, lethality, Schwartzman reactivity, adjuvant activity, and macrophage activation (2,9,12,13,25,32). Endotoxins are very stable molecules that are capable of resisting extreme temperatures and pH values (3,16,17,29,30,34,38).…”

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confidence: 99%

Inactivation of Escherichia coli Endotoxin by Soft Hydrothermal Processing

Miyamoto

Okano

Kasai

2009

Appl Environ Microbiol

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Bacterial endotoxins, also known as lipopolysaccharides, are a fever-producing by-product of gram-negative bacteria commonly known as pyrogens. It is essential to remove endotoxins from parenteral preparations since they have multiple injurious biological activities. Because of their strong heat resistance (e.g., requiring dry-heat sterilization at 250°C for 30 min) and the formation of various supramolecular aggregates, depyrogenation is more difficult than sterilization. We report here that soft hydrothermal processing, which has many advantages in safety and cost efficiency, is sufficient to assure complete depyrogenation by the inactivation of endotoxins. The endotoxin concentration in a sample was measured by using a chromogenic limulus method with an endotoxin-specific limulus reagent. The endotoxin concentration was calculated from a standard curve obtained using a serial dilution of a standard solution. We show that endotoxins were completely inactivated by soft hydrothermal processing at 130°C for 60 min or at 140°C for 30 min in the presence of a high steam saturation ratio or with a flow system. Moreover, it is easy to remove endotoxins from water by soft hydrothermal processing similarly at 130°C for 60 min or at 140°C for 30 min, without any requirement for ultrafiltration, nonselective adsorption with a hydrophobic adsorbent, or an anion exchanger. These findings indicate that soft hydrothermal processing, applied in the presence of a high steam saturation ratio or with a flow system, can inactivate endotoxins and may be useful for the depyrogenation of parenterals, including end products and medical devices that cannot be exposed to the high temperatures of dry heat treatments.

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“…Pyrogenic reactions and shock are induced in mammals upon intravenous injection of LPS at low concentrations of $1.00 ng/mL. 5,8,9 LPS can be considered stable under a wide range of temperature and pH, making their removal one of the most difficult tasks in downstream processes during protein Correspondence concerning this article should be addressed to A. M. Lopes at andreml@usp.br.…”

Section: Introductionmentioning

confidence: 99%

“…They are composed of a hydrophilic polysaccharide moiety, which is covalently linked to a hydrophobic lipid moiety-Lipid A. [3][4][5] LPS from most species consist of three distinct regions: the O-antigen region, a core oligosaccharide and lipid A. Lipid A, which is the most conserved part of LPS, is responsible for most of the biological activities, such as toxicity. 6,7 Under conditions in which the body is excessively or systemically exposed to LPS (as when small LPS concentrations reach the bloodstream), a systemic inflammatory reaction can occur, leading to multiple effects, such as endotoxin shock, tissue injury, and lethality.…”

Section: Introductionmentioning

confidence: 99%

LPS removal from an E. coli fermentation broth using aqueous two‐phase micellar system

Lopes

Magalhães

Mazzola

et al. 2010

Biotechnology Progress

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In biotechnology, endotoxin (LPS) removal from recombinant proteins is a critical and challenging step in the preparation of injectable therapeutics, as endotoxin is a natural component of bacterial expression systems widely used to manufacture therapeutic proteins. The viability of large-scale industrial production of recombinant biomolecules of pharmaceutical interest significantly depends on the separation and purification techniques used. The aim of this work was to evaluate the use of aqueous two-phase micellar system (ATPMS) for endotoxin removal from preparations containing recombinant proteins of pharmaceutical interest, such as green fluorescent protein (GFPuv). Partition assays were carried out initially using pure LPS, and afterwards in the presence of E. coli cell lysate. The ATPMS technology proved to be effective in GFPuv recovery, preferentially into the micelle-poor phase (K(GFPuv) < 1.00), and LPS removal into the micelle-rich phase (%REM(LPS) > 98.00%). Therefore, this system can be exploited as the first step for purification in biotechnology processes for removal of higher LPS concentrations.

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Evaluation of the bacterial endotoxin test for quantification of endotoxin contamination of porcine vaccines

Cited by 24 publications

References 20 publications

Macrophage Colony-Stimulating Factor Induces Vascular Endothelial Growth Factor Production in Skeletal Muscle and Promotes Tumor Angiogenesis

Macrophage Colony-Stimulating Factor Induces Vascular Endothelial Growth Factor Production in Skeletal Muscle and Promotes Tumor Angiogenesis

Inactivation of Escherichia coli Endotoxin by Soft Hydrothermal Processing

LPS removal from an E. coli fermentation broth using aqueous two‐phase micellar system

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