公开(公告)号：US20170204446A1

公开(公告)日：2017-07-20

申请号：US14996226

申请日：2016-01-15

申请人： MAURIZIO VICTOR CATTANEO ,  MARK HENRY KAMGA ,  REMCO ALEXANDER SPANJAARD

发明人： MAURIZIO VICTOR CATTANEO ,  MARK HENRY KAMGA ,  REMCO ALEXANDER SPANJAARD

IPC分类号： C12P21/00 ,  B01D15/42 ,  B01D15/14 ,  B01D15/38

CPC分类号： B01D15/14 ,  B01D15/3809 ,  B01D15/42

摘要： Described herein is a rapid continuous biomanufacturing platform process that combines a perfusion mammalian cell culture with a synchronized purification of the antibodies produced by the cell culture without the use of intermediate media holding tanks or other large retention devices. This method described herein includes continuous cell culture of mammalian cells expressing the biological of interest and comprising a cell retention device wherein the perfusion of fresh media into the reactor and hence the harvest rate of antibody containing spent media from the reactor has a rate of 1 vessel volume per day (vvd) or less obtained by glucose control with a cell density of between 40 million cell/ml and 60 million cell/nil. Immediate recovery and purification of the antibody is obtained by synchronizing the rate of perfusion with the antibody capture and elution step cycle in a column that contains affinity resin that is between 0.01 and 0.001 times the volume of the bioreactor. The perfusion rate and capture rate were perfectly synchronized by extensive method and media development resulting in equal rates and eliminating the need for holding tanks and cell bleeding. The result is an order of magnitude faster antibody production as compared to conventional fed-batch mode.