Quality evaluation of lentinan injection produced in China

Chen, Y.W.; Hu, De Jin; Cheong, Kit-Leong; Li, J.; Xie, Jing; Zhao, Jing; Li, S.P.

doi:10.1016/j.jpba.2013.02.012

Cited by 54 publications

(23 citation statements)

References 24 publications

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“…This adjuvant effect is mediated by a complex cascade of events including macrophage‐mediated cleavage of beta‐glucans to release bioactive fragments which bind to neutrophil C receptor 3 (CR3) and enhance neutrophil cytotoxicity . Beta‐glucans are produced by a range of prokaryotic and eukaryotic organisms, and both insoluble and soluble forms have been used therapeutically for many years, especially in oriental medicine . Beta‐glucans have also been reported to originate from cellulose‐based filters, cell culture raw materials, and formulation buffers used in pharmaceutical processing …”

Section: Introductionmentioning

confidence: 99%

“…8,9 Beta-glucans are produced by a range of prokaryotic and eukaryotic organisms, and both insoluble and soluble forms have been used therapeutically for many years, especially in oriental medicine. [10][11][12] Beta-glucans have also been reported to originate from cellulose-based filters, [13][14][15][16][17] cell culture raw materials, 18 and formulation buffers used in pharmaceutical processing. 15,17 Beta-glucan contamination of pharmaceutic products may be suspected when an "out of specification" result is received following endotoxin testing.…”

Section: Introductionmentioning

confidence: 99%

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Development of downstream processing to minimize beta‐glucan impurities in GMP‐manufactured therapeutic antibodies

Vigor

Emerson

Scott

et al. 2016

Biotechnology Progress

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The presence of impurities or contaminants in biological products such as monoclonal antibodies (mAb) could affect efficacy or cause adverse reactions in patients. ICH guidelines (Q6A and Q6B) are in place to regulate the level of impurities within clinical drug products. An impurity less often reported and, therefore, lacking regulatory guideline is beta‐glucan. Beta‐glucans are polysaccharides of d‐glucose monomers linked by (1‐3) beta‐glycosidic bonds, and are produced by prokaryotic and eukaryotic organisms, including plants. They may enter manufacturing processes via raw materials such as cellulose‐based membrane filters or sucrose. Here we report the detection of beta‐glucan contamination of a monoclonal IgE antibody (MOv18), manufactured in our facility for a first‐in‐human, first‐in‐class clinical trial in patients with cancer. Since beta‐glucans have potential immunostimulatory properties and can cause symptomatic infusion reactions, it was of paramount importance to identify the source of beta‐glucans in our product and to reduce the levels to clinically insignificant concentrations. We identified beta‐glucans in sucrose within the formulation buffer and within the housing storage buffer of the virus removal filter. We also detected low level beta‐glucan contamination in two of four commercially available antibodies used in oncology. Both formulation buffers contained sucrose. We managed to reduce levels of beta‐glucan in our product 10‐fold, by screening all sucrose raw material, filtering the sucrose by Posidyne® membrane filtration, and by incorporating extra wash steps when preparing the virus removal filter. The beta‐glucan levels now lie within a range that is unlikely to cause clinically significant immunological effects. © 2016 American Institute of Chemical Engineers Biotechnol. Prog., 32:1494–1502, 2016

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Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Development of downstream processing to minimize beta‐glucan impurities in GMP‐manufactured therapeutic antibodies

Vigor

Emerson

Scott

et al. 2016

Biotechnology Progress

View full text Add to dashboard Cite

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“…Quality evaluation of different lentinan injection products showed that the consistency of quality from different manufacturers in China was poor (Chen et al, 2013). Furthermore, the possibility of contamination with bacterial lipopolysaccharides (LPSs, endotoxins), which represent a potent immune modulator, may have provided false-positive results concerning the immunomodulatory features of investigated mushroom extracts.…”

Section: Introductionmentioning

confidence: 99%

Comparative chemical and biological investigations of β-glucan-containing products from shiitake mushrooms

Gründemann

Garcia-Käufer

Sauer

et al. 2015

Journal of Functional Foods

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“…:

K c / R_{θ} = 1 / M_{w} ⌊1 + (16 π^{2} n^{2} / 3 λ^{2}) R_{g}^{2} {sin}^{2} (θ / 2)⌋ + 2 A_{2} c

where the optical constant is represented as K = [4π 2 n 2 ( dn / dc ) 2 ]/( N A λ 4 ); C is the polysaccharide concentration; R θ is the Rayleigh ratio; λ is the wavelength; n is the refractive index of the solvent (0.9% NaCl aqueous solution); N A is Avogadro's number; and A 2 is the 2nd virial coefficient. The MALLS instrument was calibrated using filtered (0.2 μm, Millipore) HPLC‐grade toluene and normalized using a Dextran standard (25 kDa, low polydispersity) as previously described (Chen and others ).…”

Section: Methodsmentioning

confidence: 99%

Microwave‐Assisted Extraction, Chemical Structures, and Chain Conformation of Polysaccharides from a Novel Cordyceps Sinensis Fungus UM01

Cheong

Wang

et al. 2016

Journal of Food Science

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Cordyceps sinensis is a well-known tonic food with broad medicinal properties. The aim of the present study was to investigate the optimization of microwave-assisted extraction (MAE) and characterize chemical structures and chain conformation of polysaccharides from a novel C. sinensis fungus UM01. Ion-exchange and gel filtration chromatography were used to purify the polysaccharides. The chemical structure of purified polysaccharide was determined through gas chromatography-mass spectrometry. Moreover, high performance size exclusion chromatography combined with refractive index detector and multiangle laser light scattering were conducted to analyze the molecular weight (Mw ) and chain conformation of purified polysaccharide. Based on the orthogonal design L9 , optimal MAE conditions could be obtained through 1300 W of microwave power, with a 5-min irradiation time at a solid to water ratio of 1:60, generating the highest extraction yield of 6.20%. Subsequently, the polysaccharide UM01-S1 was purified. The UM01-S1 is a glucan-type polysaccharide with a (1→4)-β-d-glucosyl backbone and branching points located at O-3 of Glcp with a terminal-d-Glcp. The Mw , radius of gyration (Rg ) and hydrodynamic radius (Rh ) of UM01-S1 were determined as 5.442 × 10(6) Da, 21.8 and 20.2 nm, respectively. Using the polymer solution theory, the exponent (ν) value of the power law function was calculated as 0.38, and the shape factor (ρ = Rg /Rh ) was 1.079, indicating that UM01-S1 has a sphere-like conformation with a branched structure in an aqueous solution. These results provide fundamental information for the future application of polysaccharides from cultured C. sinensis in health and functional food area.

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Quality evaluation of lentinan injection produced in China

Cited by 54 publications

References 24 publications

Development of downstream processing to minimize beta‐glucan impurities in GMP‐manufactured therapeutic antibodies

Development of downstream processing to minimize beta‐glucan impurities in GMP‐manufactured therapeutic antibodies

Comparative chemical and biological investigations of β-glucan-containing products from shiitake mushrooms

Microwave‐Assisted Extraction, Chemical Structures, and Chain Conformation of Polysaccharides from a Novel Cordyceps Sinensis Fungus UM01

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