IRX-2 MODIFIED MANUFACTURING PROCESS
    3.
    发明公开
    IRX-2 MODIFIED MANUFACTURING PROCESS 有权
    IRX-2改性制造工艺

    公开(公告)号:EP2276850A2

    公开(公告)日:2011-01-26

    申请号:EP09743225.6

    申请日:2009-04-14

    IPC分类号: C12P21/04 C12N5/02 C12N13/00

    摘要: A highly efficient method of making a primary cell derived biologic by purifying mononuclear cells (MNCs) in a automated cell processor to remove contaminating cells by loading leukocytes onto lymphocyte separation medium (LSM) and centrifuging the medium to obtain purified MNCs, storing the MNCs overnight in a closed sterile bag system, stimulating an induction mixture of the MNCs with phytohemagglutinin (PHA) or other mitogen and ciprofloxacin in a scalable cell culture device and producing a primary cell derived biologic from the MNCs, removing the mitogen from the induction mixture by filtering, incubating the induction mixture, clarifying the induction mixture by filtering to obtain a primary cell derived biologic supernatant, and clearing the primary cell derived biologic supernatant from adventitious agents by anion exchange chromatography, filtration. A closed system prevents contamination of the resulting primary cell derived biologic. An automated method of purifying cells. A method of scalably inducing cells.

    摘要翻译: 通过在自动化细胞处理器中纯化单核细胞(MNC)以通过将白细胞装载到淋巴细胞分离培养基(LSM)上并将培养基离心以获得纯化的MNC来去除污染细胞,将MNC存储过夜 在封闭的无菌袋系统中,在可缩放的细胞培养装置中刺激具有植物凝集素(PHA)或其他促分裂原和环丙沙星的MNC的诱导混合物,并从MNC产生源自原代细胞的生物制剂,通过过滤从诱导混合物中去除促分裂原 ,孵育诱导混合物,通过过滤澄清诱导混合物以获得源自原代细胞的生物学上清液,并通过阴离子交换色谱法过滤来自外源的源自原代细胞的生物学上清液,过滤。 封闭的系统可防止由此产生的原代细胞衍生生物的污染。 一种纯化细胞的自动化方法。 一种可分级诱导细胞的方法。