VIRAL CLEARANCE BY LOW PH HOLD
    2.
    发明申请

    公开(公告)号:WO2021231463A1

    公开(公告)日:2021-11-18

    申请号:PCT/US2021/031825

    申请日:2021-05-11

    Abstract: Methods for viral clearance using low pH hold based on a statistical design of experiment are provided. Several factors are evaluated to characterize the impacts of a low pH hold step for virus inactivation, including the factors of pH conditions, conductivity conditions, protein type, temperature, acid titrant, spike timing, and post-spike filtration. In addition to the effect of pH on virus inactivation, an increase in ionic strength through manipulating the conductivity can be a key component that influences virus inactivation kinetics.

    METHODS AND SYSTEMS FOR CHROMATOGRAPHY DATA ANALYSIS
    3.
    发明申请
    METHODS AND SYSTEMS FOR CHROMATOGRAPHY DATA ANALYSIS 审中-公开
    色谱数据分析方法和系统

    公开(公告)号:WO2018081203A1

    公开(公告)日:2018-05-03

    申请号:PCT/US2017/058190

    申请日:2017-10-25

    Abstract: Embodiments of the present disclosure are directed to methods and systems for assessing integrity of chromatography columns, systems, and processes. The methods and systems can comprise one or more of extracting a block and signal combination for analysis, performing a transition analysis, performing one or more statistical process controls, and/or implementing in-process controls based on the statistical process controls.

    Abstract translation: 本公开的实施例涉及用于评估色谱柱,系统和过程的完整性的方法和系统。 该方法和系统可以包括提取用于分析的块和信号组合,执行转换分析,执行一个或多个统计过程控制,和/或基于统计过程控制实施过程中控制中的一个或多个。

    PURIFICATION PLATFORM FOR BISPECIFIC ANTIBODIES
    4.
    发明申请
    PURIFICATION PLATFORM FOR BISPECIFIC ANTIBODIES 审中-公开
    双特异性抗体的纯化平台

    公开(公告)号:WO2016018740A3

    公开(公告)日:2016-02-04

    申请号:PCT/US2015/041936

    申请日:2015-07-24

    Abstract: High resolution protein A chromatography employing a chaotropic agent and pH gradient or pH step elution buffer results in improved peak resolution between closely related molecular species. Bispecific antibodies containing a protein A-binding-ablating substitution CH3 domain paired with a protein A-binding CH3 domain are separated with high peak resolution from monospecific antibodies containing a protein A-binding-ablating substituted CH3 domain paired with the protein A-binding-ablating substituted CH3 domain and monospecific antibodies containing a protein A-binding CH3 domain paired with the protein A-binding CH3 domain. Useful chaotropic agents include magnesium chloride and calcium chloride.

    Abstract translation: 使用离液剂和pH梯度或pH梯度洗脱缓冲液的高分辨率蛋白A色谱导致密切相关的分子种类之间的峰分辨率改善。 含有与蛋白质A结合CH3结构域配对的蛋白质A结合消融取代CH3结构域的双特异性抗体以高峰解析度从包含与蛋白质A结合消融取代CH3结构域配对的单特异性抗体的单特异性抗体分离, 消融取代的CH3结构域和含有蛋白A结合CH3结构域与蛋白A结合CH3结构域配对的单特异性抗体。 有用的离液剂包括氯化镁和氯化钙。

    SYSTEMS AND METHODS FOR CHROMATOGRAPHY USE AND REGENERATION

    公开(公告)号:WO2021061790A1

    公开(公告)日:2021-04-01

    申请号:PCT/US2020/052243

    申请日:2020-09-23

    Abstract: Aspects of the present disclosure relate to a method of regenerating a hydrophobic interaction chromatography column to which a load mass has been applied, the method comprising passing one or more column volumes of an alkaline solution through hydrophobic interaction media within the column, wherein the alkaline solution exhibits a pH of between about 10 and about 14, and a conductivity of between 0.5 mS/cm and about 10 mS/cm, wherein material bound to the hydrophobic interaction media is removed. In some cases, the alkaline solution may include sodium hydroxide at a concentration of between, e.g., about 0.1 mM and 10 mM.

    METHOD FOR VIRAL INACTIVATION
    7.
    发明申请

    公开(公告)号:WO2021021260A1

    公开(公告)日:2021-02-04

    申请号:PCT/US2020/029468

    申请日:2020-04-23

    Abstract: Embodiments of the present disclosure are directed to systems and methods for modulating pH in a mixture containing a polypeptide. The pH may be modulated for any suitable purpose, e.g., inactivating virus in the mixture. Methods may include eluting, from a chromatography column, a mixture (e.g., an eluate) having a pH greater than, e.g., 3.9 and less than, e.g., 8.5. Methods may further include one or more of measuring a protein concentration of the mixture and measuring a pH of the mixture. An amount of acid necessary to reduce the pH of the mixture to a target pH may then be calculated based on the protein concentration of the mixture, the pH of the mixture, or both. After an acid addition amount is calculated, a portion of acid may be added to the mixture, wherein the portion of acid is sufficient to achieve the target pH.

    PROCESS FOR REDUCING SUBVISIBLE PARTICLES IN A PHARMACEUTICAL FORMULATION
    8.
    发明申请
    PROCESS FOR REDUCING SUBVISIBLE PARTICLES IN A PHARMACEUTICAL FORMULATION 审中-公开
    在药物制剂中减少可分散颗粒的方法

    公开(公告)号:WO2016057739A1

    公开(公告)日:2016-04-14

    申请号:PCT/US2015/054600

    申请日:2015-10-08

    CPC classification number: A61K47/22 A61K39/39591 A61K47/26

    Abstract: The present disclosure provides a stable protein composition containing a surfactant and having less than 400 subvisible particles of 10 microns or greater diameter per container, or less than 10,000 subvisible particles of 2 microns or greater per container. A method of manufacturing such a stable protein composition is disclosed, which includes a unit of operation that removes or decreases an esterase activity that degrades the surfactant. The unit of operation may be hydrophobic interaction chromatography or filtration, mixed mode chromatography, or the like.

    Abstract translation: 本公开内容提供了包含表面活性剂并且具有每个容器具有小于或等于10微米或更大直径的小于400个可隐形颗粒的稳定的蛋白质组合物,或每个容器小于10,000个可隐形的2微米或更大的颗粒。 公开了制备这种稳定蛋白质组合物的方法,其包括去除或降低降解表面活性剂的酯酶活性的操作单元。 操作单元可以是疏水相互作用层析或过滤,混合模式色谱法等。

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