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11 条记录 (耗时 0.019 秒)

    Stabilization of biological and pharmaceutical products during thermal inactivation of viral and bacterial contaminants
    2.
    发明授权
    Stabilization of biological and pharmaceutical products during thermal inactivation of viral and bacterial contaminants 失效
    在病毒和细菌污染物的热失活期间稳定生物和药物产品

    公开(公告)号：US4876241A

    公开(公告)日：1989-10-24

    申请号：US195318

    申请日：1988-05-18

    申请人： Fred Feldman ,  Mark S. Klekamp ,  Michael E. Hrinda ,  Arthur B. Shaw ,  Sudhish Chandra

    发明人： Fred Feldman ,  Mark S. Klekamp ,  Michael E. Hrinda ,  Arthur B. Shaw ,  Sudhish Chandra

    IPC分类号： A61L2/00

    CPC分类号： A61L2/0023 ,  A61L2/0005

    摘要： A method of inactivating pathogens in proteinaceous biological and pharmaceutical products which comprises: mixing the product in an aqueous solution with one or more primary stabilizers selected from the group consisting of sugars and sugar alcohols and one or more secondary stabilizers selected from the group consisting of sodium acetate, potassium acetate, lithium acetate, magnesium acetate, ammonium acetate, barium acetate, sodium sulfate, ammonium sulfate, lithium sulfate, potassium sulfate and magnesium sulfate; and subjecting said aqueous solution to a pathogen inactivating process.

    摘要翻译： 一种灭活蛋白质生物和药物产品中的病原体的方法，其包括：将产物在水溶液中与一种或多种主要稳定剂混合，所述主要稳定剂选自糖和糖醇，以及一种或多种二级稳定剂，其选自钠 乙酸钾，乙酸钾，乙酸锂，乙酸镁，乙酸铵，乙酸钡，硫酸钠，硫酸铵，硫酸锂，硫酸钾和硫酸镁; 并使所述水溶液进行病原体灭活过程。

    Preparation of factor IX
    4.
    发明授权
    Preparation of factor IX 失效
    因子IX的制备

    公开(公告)号：US06280729B1

    公开(公告)日：2001-08-28

    申请号：US09524206

    申请日：2000-03-13

    申请人： Chin C. Huang ,  Takashi Enkoji ,  Laura Ho ,  Richard R. Kleszynski ,  Richard L. Weeks ,  Fred Feldman

    发明人： Chin C. Huang ,  Takashi Enkoji ,  Laura Ho ,  Richard R. Kleszynski ,  Richard L. Weeks ,  Fred Feldman

    IPC分类号： A61K3848

    CPC分类号： C12N9/644 ,  A61K9/0019 ,  A61K38/4846 ,  A61K47/02 ,  C07K16/40 ,  C12N9/96 ,  C12Y304/21022

    摘要： A novel method of protecting blood coagulation factor IX from proteases during purification or storage is disclosed. High concentrations of one or more water soluble organic or inorganic salts are used to stabilize factor IX, contained within blood plasma-derived solutions, or contained within solutions derived from other sources, against conversion to clinically unacceptable peptide structures such as factor IXa, and/or degraded factor IX peptides. The technique is useful in stabilizing intermediate purity factor IX preparations during purification, and in maintaining the integrity of purified factor IX during long term storage. Stable high specific activity factor IX preparations are also disclosed.

    摘要翻译： 公开了一种在纯化或储存期间保护凝血因子IX免受蛋白酶的新方法。 使用高浓度的一种或多种水溶性有机或无机盐来稳定血液来源的溶液中所含的因子IX，或者包含在源自其它来源的溶液中，以防止转化为临床上不可接受的肽结构，如因子IXa和/ 或降解因子IX肽。 该技术在纯化期间稳定中间纯度因子IX制剂并且在长期储存期间维持纯化的因子IX的完整性是有用的。 还公开了稳定的高比活性因子IX制剂。