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    • 2. 发明申请
    • Analysis of Saccharide Vaccines Without Interference
    • 没有干扰的糖类疫苗的分析
    • US20080286300A1
    • 2008-11-20
    • US10593005
    • 2005-03-17
    • Angela BardottiDaniela ProiettiStefano Ricci
    • Angela BardottiDaniela ProiettiStefano Ricci
    • A61K39/095G01N33/00G06F19/00A61P31/04
    • G01N33/56911A61K39/095A61K2039/6087G01N30/02G01N33/5308G01N2333/22G01N2400/10Y10T436/143333B01D15/363
    • The invention is based on methods that allow analysis of mixed meningococcal saccharides from multiple serogroups even though they share monosaccharide units. With a combination of saccharides from serogroups C, W135 and Y, the invention analyses sialic acid, glucose and galactose content. The glucose and galactose results are used to directly quantify saccharides from serogroups Y and W135, respectively, and the combined glucose and galactose content is subtracted from the sialic acid content to quantify saccharides from serogroup C. The three serogroups can thus be resolved even though their monosaccharide contents overlap. The three different monosaccharide analyses can be performed on the same material, without interference between the monosaccharides and without interference from any other saccharide materials in the composition (e.g. lyophilisation stabilisers). The method can be used to analyse total and free saccharide in conjugate vaccines and simplifies quality control of vaccines containing capsular saccharides from multiple serogroups.
    • 本发明基于允许分析来自多个血清群的混合脑膜炎球菌糖的方法,即使它们共享单糖单元。 利用来自血清群C,W135和Y的糖的组合,本发明分析唾液酸,葡萄糖和半乳糖含量。 葡萄糖和半乳糖结果分别用于从血清组Y和W135直接定量糖,并从唾液酸含量中减去葡萄糖和半乳糖的含量,从血清群C中定量糖。因此,三个血清群可以解决,即使它们 单糖含量重叠。 三种不同的单糖分析可以在相同的材料上进行,而不影响单糖之间的干扰,并且不受组合物中任何其他糖类物质(例如冻干稳定剂)的干扰。 该方法可用于分析结合疫苗中的总和游离糖,并简化了来自多个血清群的含有荚膜糖的疫苗的质量控制。
    • 7. 发明申请
    • ANALYSIS OF SACCHARIDE VACCINES WITHOUT INTERFERENCE
    • 没有干扰的沙门菌疫苗的分析
    • US20120171241A1
    • 2012-07-05
    • US13418211
    • 2012-03-12
    • Angela BardottiDaniela ProiettiStefano Ricci
    • Angela BardottiDaniela ProiettiStefano Ricci
    • A61K39/385A61P37/04G01N33/48
    • G01N33/56911A61K39/095A61K2039/6087G01N30/02G01N33/5308G01N2333/22G01N2400/10Y10T436/143333B01D15/363
    • The invention is based on methods that allow analysis of mixed meningococcal saccharides from multiple serogroups even though they share monosaccharide units. With a combination of saccharides from serogroups C, W135 and Y, the invention analyses sialic acid, glucose and galactose content. The glucose and galactose results are used to directly quantify saccharides from serogroups Y and W135, respectively, and the combined glucose and galactose content is subtracted from the sialic acid content to quantify saccharides from serogroup C. The three serogroups can thus be resolved even though their monosaccharide contents overlap. The three different monosaccharide analyses can be performed on the same material, without interference between the monosaccharides and without interference from any other saccharide materials in the composition (e.g. lyophilisation stabilisers). The method can be used to analyse total and free saccharide in conjugate vaccines and simplifies quality control of vaccines containing capsular saccharides from multiple serogroups.
    • 本发明基于允许分析来自多个血清群的混合脑膜炎球菌糖的方法,即使它们共享单糖单元。 利用来自血清群C,W135和Y的糖的组合,本发明分析唾液酸,葡萄糖和半乳糖含量。 葡萄糖和半乳糖结果分别用于从血清组Y和W135直接定量糖,并从唾液酸含量中减去葡萄糖和半乳糖的含量,从血清群C中定量糖。因此,三个血清群可以被解决,即使它们 单糖含量重叠。 三种不同的单糖分析可以在相同的材料上进行,而不影响单糖之间的干扰,并且不受组合物中任何其他糖类物质(例如冻干稳定剂)的干扰。 该方法可用于分析结合疫苗中的总和游离糖,并简化了来自多个血清群的含有荚膜糖的疫苗的质量控制。
    • 8. 发明授权
    • Analysis of saccharide vaccines without interference
    • 分析糖类疫苗无干扰
    • US08137680B2
    • 2012-03-20
    • US10593005
    • 2005-03-17
    • Angela BardottiDaniela ProiettiStefano Ricci
    • Angela BardottiDaniela ProiettiStefano Ricci
    • A61K39/095G01N31/00G01N31/02G01N21/00G01N30/02G01J3/42
    • G01N33/56911A61K39/095A61K2039/6087G01N30/02G01N33/5308G01N2333/22G01N2400/10Y10T436/143333B01D15/363
    • The invention is based on methods that allow analysis of mixed meningococcal saccharides from multiple serogroups even though they share monosaccharide units. With a combination of saccharides from serogroups C, W135 and Y, the invention analyses sialic acid, glucose and galactose content. The glucose and galactose results are used to directly quantify saccharides from serogroups Y and W135, respectively, and the combined glucose and galactose content is subtracted from the sialic acid content to quantify saccharides from serogroup C. The three serogroups can thus be resolved even though their monosaccharide contents overlap. The three different monosaccharide analyses can be performed on the same material, without interference between the monosaccharides and without interference from any other saccharide materials in the composition (e.g. lyophilisation stabilisers). The method can be used to analyse total and free saccharide in conjugate vaccines and simplifies quality control of vaccines containing capsular saccharides from multiple serogroups.
    • 本发明基于允许分析来自多个血清群的混合脑膜炎球菌糖的方法,即使它们共享单糖单元。 利用来自血清群C,W135和Y的糖的组合,本发明分析唾液酸,葡萄糖和半乳糖含量。 葡萄糖和半乳糖结果分别用于从血清组Y和W135直接定量糖,并从唾液酸含量中减去葡萄糖和半乳糖的含量,从血清群C中定量糖。因此,三个血清群可以被解决,即使它们 单糖含量重叠。 三种不同的单糖分析可以在相同的材料上进行,而不影响单糖之间的干扰,并且不受组合物中任何其他糖类物质(例如冻干稳定剂)的干扰。 该方法可用于分析结合疫苗中的总和游离糖,并简化了来自多个血清群的含有荚膜糖的疫苗的质量控制。
    • 10. 发明申请
    • Liquid Chromatography-Mass Spectrometry Analysis of Samples Using Ionic Eluent Comprising a Volatile Ionic Salt
    • 使用包含挥发性离子盐的离子洗脱液的样品的液相色谱 - 质谱分析
    • US20100219335A1
    • 2010-09-02
    • US12085507
    • 2006-12-05
    • Angela BardottiAlessandro Pianigiani
    • Angela BardottiAlessandro Pianigiani
    • H01J49/04H01J49/26A61K39/02
    • G01N30/7233C07K1/18G01N30/02G01N30/96B01D15/363B01D15/426
    • The use of an ionic eluent in ion exchange chromatography for analysing a sample comprising an analyte, wherein the ionic eluent comprises a volatile ionic salt, in particular an ammonium salt, is described. Such eluents are shown to be compatible with mass spectrometry (MS), providing clean mass spectra of the analyte. Furthermore, eluates from ion exchange chromatography may be advantageously analysed with MS without additional on-line or off-line devices for desalting or suppressing salts in the eluent. Important information concerning the chemical structure and composition of a sample may therefore be obtained with ion chromatography-MS by utilising the invention. The invention also provides a method of analysing a sample (e.g. a vaccine) comprising an analyte (e.g. a saccharide) by ion chromotography-MS by employing an ionic eluent, wherein the ionic eluent comprises a volatile ionic salt. An apparatus for analysing a sample comprising an analyte is also disclosed.
    • 在离子交换层析中使用离子洗脱液用于分析包含分析物的样品,其中离子洗脱液包含挥发性离子盐,特别是铵盐。 显示这种洗脱液与质谱(MS)相容,提供分析物的清晰质谱。 此外,离子交换层析的洗脱液可以有利地用MS分析,而无需额外的在线或离线装置用于在洗脱液中脱盐或抑制盐。 因此,通过利用本发明,可以通过离子色谱法MS获得关于样品的化学结构和组成的重要信息。 本发明还提供了通过使用离子洗脱液通过离子色谱-MS分析包含分析物(例如糖)的样品(例如疫苗)的方法,其中离子洗脱液包含挥发性离子盐。 还公开了一种用于分析包含分析物的样品的装置。