Stabilized liquid polypeptide formulations
    13.
    发明申请
    Stabilized liquid polypeptide formulations 审中-公开
    稳定液体多肽制剂

    公开(公告)号:US20060210557A1

    公开(公告)日:2006-09-21

    申请号:US11342252

    申请日:2006-01-27

    摘要: The present invention provides formulations for maintaining the stability of polypeptides, in particular, therapeutic antigen-binding polypeptides such as antibodies and the like, for example, anti-Aβ antibodies. The formulations generally include an antioxidant in a sufficient amount as to inhibit by-product formation, for example, the formation of high molecular weight polypeptide aggregates, low molecular weight polypeptide degradation fragments, and mixtures thereof. The formulations of the invention optionally comprise a tonicity agent, such as mannitol, and a buffering agent or amino acid such as histidine, and thus, the formulations are suitable for several different routes of administration.

    摘要翻译: 本发明提供用于维持多肽的稳定性,特别是治疗性抗原结合多肽如抗体等的抗体,例如抗Aβ抗体的制剂。 制剂通常包括足够量的抗氧化剂以抑制副产物形成,例如形成高分子量多肽聚集体,低分子量多肽降解片段及其混合物。 本发明的制剂任选地包含张度剂,例如甘露糖醇,缓冲剂或氨基酸,例如组氨酸,因此,该制剂适合于几种不同的给药途径。

    Lyophilization methods and apparatuses
    17.
    发明申请
    Lyophilization methods and apparatuses 审中-公开
    冻干方法和装置

    公开(公告)号:US20080098614A1

    公开(公告)日:2008-05-01

    申请号:US11906622

    申请日:2007-10-03

    IPC分类号: F26B5/06 F26B19/00

    CPC分类号: F26B5/06

    摘要: A method and apparatus for optimizing the primary drying step of a lyophilization cycle of a biological or pharmaceutical material. In one aspect, the invention is a method for lyophilizing a material comprising the steps of calculating a designed primary drying cycle for the material based on a product temperature profile for the material and modifying both a chamber pressure and a shelf temperature according to a designed primary drying cycle during a primary drying step. In another aspect, the invention is an apparatus for lyophilizing a material according to a designed primary drying cycle comprising a computer-readable medium, a processor in electrical communication with the computer-readable medium, a chamber pressure module in electrical communication with the processor, and a shelf temperature module in electrical communication with the processor.

    摘要翻译: 一种用于优化生物或药物材料的冻干循环的初级干燥步骤的方法和装置。 一方面,本发明是一种用于冻干材料的方法,包括以下步骤:基于材料的产品温度分布计算材料的设计的初级干燥循环,并根据设计的主要原料改变室压力和搁板温度 一次干燥步骤中的干燥循环。 另一方面,本发明是一种用于根据设计的初级干燥循环对材料进行冻干的装置,包括计算机可读介质,与计算机可读介质电连通的处理器,与处理器电通信的室压模块, 以及与处理器电连通的搁架温度模块。

    Prediction of relative polypeptide solubility by polyethylene glycol precipitation
    18.
    发明申请
    Prediction of relative polypeptide solubility by polyethylene glycol precipitation 审中-公开
    通过聚乙二醇沉淀预测相对多肽溶解度

    公开(公告)号:US20080003686A1

    公开(公告)日:2008-01-03

    申请号:US11804191

    申请日:2007-05-17

    IPC分类号: G01N33/00

    CPC分类号: G01N33/68 G01N33/6803

    摘要: A method is described for predicting the relative solubility of a polypeptide using polyethylene glycol (PEG) based volume exclusion precipitation. Different polypeptides can be tested for their solubilities relative to each other or relative to a reference. A single polypeptide can be tested for its relative solubility under different experimental conditions. The solubility determinations can be made by comparison based on graphs plotting the log solubility of the polypeptide against a range of PEG concentrations. Additionally, a method is provided for the high throughput visual or automated screening of multiple polypeptides for relative solubility differences, in a method that can omit the step of measuring the actual solubility or actual amount of precipitation of each sample at each PEG concentration.

    摘要翻译: 描述了一种用于使用基于聚乙二醇(PEG)的体积排阻沉淀来预测多肽的相对溶解度的方法。 可以测试不同的多肽相对于彼此或相对于参考物的溶解度。 可以在不同的实验条件下测试单个多肽的相对溶解度。 可以基于绘制多肽对一定范围的PEG浓度的对数溶解度的图进行比较来进行溶解度测定。 此外,提供了一种方法,可以省略在每个PEG浓度下测量每个样品的实际溶解度或实际沉淀量的步骤,用于多个多肽的高通量视觉或自动筛选相对溶解度差异。