Methods and systems for analysis of samples containing particles used for gene delivery

    公开(公告)号:US11827946B2

    公开(公告)日:2023-11-28

    申请号:US18087772

    申请日:2022-12-22

    Applicant: ProteinSimple

    CPC classification number: C12Q1/70 G16B20/00

    Abstract: Embodiments disclosed include systems, devices, and methods for analysis of samples containing particles used for gene delivery to determine a quality of the sample and/or an indication that the gene delivery particles are in a full, partial, and/or empty state. The present disclosure also relates to determining a protein and/or NA content in samples with known proportions of gene delivery particles in a full, partial, and/or empty state and based on the determination, establish a relationship between NA content and proportions of gene delivery particles in a full state. The present disclosure also relates to using such an established relationship to predict a proportion of the gene delivery particles in a full, partial, and/or empty state in test samples having the gene delivery particles in an unknown state.

    Dual wavelength isoelectric focusing for determining drug load in antibody drug conjugates

    公开(公告)号:US09804079B2

    公开(公告)日:2017-10-31

    申请号:US13866164

    申请日:2013-04-19

    Applicant: ProteinSimple

    Inventor: Jiaqi Wu

    Abstract: Provided herein are IEF focusing methods for determining the number of drug molecules present in at least one antibody-drug conjugate (ADC) species subpopulation. In one embodiment, the method comprises performing free solution isoelectric focusing on a sample comprising at least one ADC species, to obtain a focused sample. The absorbance of the sample at two different wavelengths is then measured, for example, over a range of pI values. Absorbance values at the two different wavelengths are compared at at least one corresponding pI value, where the at least one corresponding pI value is the pI of the ADC subpopulation. The number of drug molecules in the at least one ADC species subpopulation is then determined based on the comparison. The methods provided herein can also be used to determine the number of specific binding pair members bound to its target specific binding pair member.

    Method and apparatus for precise selection and extraction of a focused component in isoelectric focusing performed in micro-channels
    3.
    发明授权
    Method and apparatus for precise selection and extraction of a focused component in isoelectric focusing performed in micro-channels 有权
    用于在微通道中进行的等电聚焦中精确选择和提取聚焦成分的方法和装置

    公开(公告)号:US09377440B2

    公开(公告)日:2016-06-28

    申请号:US13573799

    申请日:2012-10-03

    Applicant: ProteinSimple

    Abstract: An apparatus and method are disclosed for the precise selection and extraction of a selected analyte in a focused zone produced by isoelectric focusing performed in micro-channels. A cross-channel microfluidic device comprises a sample mixture introduction and separation channel and an extraction channel, which are in fluid communication with each other at a point of intersection. Means are provided for selectively moving the pattern of separated zones following cIEF to the intersection point, and means are provided for applying an extraction pressure to direct a single zone containing a selected analyte into and then out of the extraction channel for collection.

    Abstract translation: 公开了用于精确选择和提取在微通道中执行的等电聚焦产生的聚焦区域中的选定分析物的装置和方法。 交叉通道微流体装置包括在交点处彼此流体连通的样品混合物引入和分离通道和提取通道。 提供了用于选择性地将cIEF之后的分离区域的图案移动到交点的装置,并且提供用于施加提取压力以将包含所选分析物的单个区域引导到提取通道中并随后从提取通道收集的装置。

    DUAL WAVELENGTH ISOELECTRIC FOCUSING FOR DETERMINING DRUG LOAD IN ANTIBODY DRUG CONJUGATES
    4.
    发明申请
    DUAL WAVELENGTH ISOELECTRIC FOCUSING FOR DETERMINING DRUG LOAD IN ANTIBODY DRUG CONJUGATES 有权
    用于确定抗体药物联合中药物负载的双波长光电聚焦

    公开(公告)号:US20130280815A1

    公开(公告)日:2013-10-24

    申请号:US13866164

    申请日:2013-04-19

    Applicant: PROTEINSIMPLE

    Inventor: Jiaqi Wu

    Abstract: Provided herein are IEF focusing methods for determining the number of drug molecules present in at least one antibody-drug conjugate (ADC) species subpopulation. In one embodiment, the method comprises performing free solution isoelectric focusing on a sample comprising at least one ADC species, to obtain a focused sample. The absorbance of the sample at two different wavelengths is then measured, for example, over a range of pI values. Absorbance values at the two different wavelengths are compared at at least one corresponding pI value, where the at least one corresponding pI value is the pI of the ADC subpopulation. The number of drug molecules in the at least one ADC species subpopulation is then determined based on the comparison. The methods provided herein can also be used to determine the number of specific binding pair members bound to its target specific binding pair member.

    Abstract translation: 本文提供了用于确定存在于至少一种抗体 - 药物偶联物(ADC)物种亚群中的药物分子数目的IEF聚焦方法。 在一个实施方案中,该方法包括对包含至少一种ADC种类的样品进行自由溶液等电聚焦,以获得聚焦样品。 然后测量样品在两个不同波长处的吸光度,例如在pI值的范围内。 在两个不同波长处的吸光度值在至少一个对应的pI值进行比较,其中至少一个对应的pI值是ADC亚群的pI。 然后基于比较来确定至少一个ADC种子亚群中的药物分子的数量。 本文提供的方法还可用于确定与其靶特异性结合对成员结合的特异性结合对成员的数目。

    Methods and systems for analysis of samples containing particles used for gene delivery

    公开(公告)号:US12209291B2

    公开(公告)日:2025-01-28

    申请号:US18493087

    申请日:2023-10-24

    Applicant: ProteinSimple

    Abstract: Embodiments disclosed include systems, devices, and methods for analysis of samples containing particles used for gene delivery to determine a quality of the sample and/or an indication that the gene delivery particles are in a full, partial, and/or empty state. The present disclosure also relates to determining a protein and/or NA content in samples with known proportions of gene delivery particles in a full, partial, and/or empty state and based on the determination, establish a relationship between NA content and proportions of gene delivery particles in a full state. The present disclosure also relates to using such an established relationship to predict a proportion of the gene delivery particles in a full, partial, and/or empty state in test samples having the gene delivery particles in an unknown state.

    Dual wavelength isoelectric focusing for determining drug load in antibody drug conjugates

    公开(公告)号:US10753859B2

    公开(公告)日:2020-08-25

    申请号:US15793434

    申请日:2017-10-25

    Applicant: ProteinSimple

    Inventor: Jiaqi Wu

    Abstract: Provided herein are IEF focusing methods for determining the number of drug molecules present in at least one antibody-drug conjugate (ADC) species subpopulation. In one embodiment, the method comprises performing free solution isoelectric focusing on a sample comprising at least one ADC species, to obtain a focused sample. The absorbance of the sample at two different wavelengths is then measured, for example, over a range of pI values. Absorbance values at the two different wavelengths are compared at at least one corresponding pI value, where the at least one corresponding pI value is the pI of the ADC subpopulation. The number of drug molecules in the at least one ADC species subpopulation is then determined based on the comparison. The methods provided herein can also be used to determine the number of specific binding pair members bound to its target specific binding pair member.

    Systems and methods for fractionation and collection of analytes in a sample

    公开(公告)号:US11420202B1

    公开(公告)日:2022-08-23

    申请号:US17463326

    申请日:2021-08-31

    Applicant: ProteinSimple

    Abstract: Embodiments include systems, apparatuses, and methods to efficiently separate analytes in a sample and elute fractions of the separated analytes. In some embodiments, a method includes introducing a sample in a capillary with a first end ionically coupled to a first running buffer and a second end ionically coupled to a second running buffer to form a pH gradient. The method includes applying a voltage between the first running buffer and the second running buffer, to separate a plurality of analytes in the sample. The method includes disposing the second end of the capillary in a collection well including a chemical mobilizer and applying a voltage to elute one or more analytes from the plurality of analytes in the sample, that have been separated, into the collection well. Embodiments include detection methods to monitor separation of analytes, mobilization of analytes, and/or elution of fractions containing analytes.

    Methods and systems for analysis of samples containing particles used for gene delivery

    公开(公告)号:US11535900B1

    公开(公告)日:2022-12-27

    申请号:US17554830

    申请日:2021-12-17

    Applicant: ProteinSimple

    Abstract: Embodiments disclosed include systems, devices, and methods for analysis of samples containing particles used for gene delivery to determine a quality of the sample and/or an indication that the gene delivery particles are in a full, partial, and/or empty state. The present disclosure also relates to determining a protein and/or NA content in samples with known proportions of gene delivery particles in a full, partial, and/or empty state and based on the determination, establish a relationship between NA content and proportions of gene delivery particles in a full state. The present disclosure also relates to using such an established relationship to predict a proportion of the gene delivery particles in a full, partial, and/or empty state in test samples having the gene delivery particles in an unknown state.

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