公开(公告)号：EP3131589A1

公开(公告)日：2017-02-22

申请号：EP15720615.2

申请日：2015-04-15

申请人： Boehringer Ingelheim International GmbH

发明人： COFFMAN, Jonathan ,  GOBY, Jeff ,  GODFREY, Scott ,  OROZCO, Raquel ,  VOGEL, Jens, Holger

IPC分类号： A61L2/00 ,  C07K1/16 ,  C12N7/04 ,  C12N7/06

CPC分类号： C12N7/00 ,  A61L2/0082 ,  A61L2202/21 ,  C07K1/14 ,  C07K1/16 ,  C12N2710/00063

摘要： Methods for continuously inactivating virus during manufacture of a biological product are provided. The methods include steps of (1) combining (a) a composition including a biological product, and (b) a composition including a virus-inactivation reagent, to obtain (c) a treatment composition having a predetermined property for inactivation of a virus, (2) confirming that the treatment composition exhibits the predetermined property, (3) transferring the treatment composition to a treatment vessel that includes an inlet, an outlet, and a static mixer, the transferring occurring at the inlet, (4) incubating the treatment composition in the treatment vessel at a predetermined temperature while the treatment composition flows at a predetermined rate and contacts the static mixer, and (5) collecting the treatment composition from the treatment vessel at the outlet, wherein steps (1) to (5) are carried out continuously. Apparatuses and systems including such a treatment vessel are also provided.

摘要翻译： 提供了用于生产生物制品的过程中不断灭活病毒的方法。 该方法包括的步骤：（1）将（a）一种组合物，包括生物的产品，和（b）的组合物包括病毒灭活试剂，以获得具有针对病毒的灭活的预定属性（c）一种治疗组合物， （2）确认没有治疗组合物表现出的预定性质，（3）的处理组合物处理容器没有转移环包括在入口到出口，和一个静态混合器，该传递环处出现入口，（4）孵育所治疗 在预定的温度，同时将处理组合物以预定的速率，并接触静态混合器流动，和（5）收集从处理容器中的处理组合物在出口处，worin步骤（1）至（5）是在处理容器中的组合物 连续进行。 因此提供的装置和系统包括寻求处理容器。