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1. 发明公开

EP4063850A1 CHROMATOGRAPHY COLUMN QUALIFICATION DEVICE WITH TRANSITION ANALYSIS 无效
公开(公告)号：EP4063850A1
公开(公告)日：2022-09-28
申请号：EP22172686.2
申请日：2019-04-19
申请人： Janssen Biotech, Inc.
发明人： RANDOLPH, Paul
IPC分类号： G01N30/86 , G01N30/88 , C07K16/24 , A61K38/00 , G01N30/56
摘要： The present disclosure is directed to a method of operating a chromatography column. This method involves collecting column outlet signal and accumulated flow parameters at two or more intervals of at least one mobile phase transition front during operation of the chromatography column comprising column packing. A model gamma cumulative distribution curve is determined based on the collected column outlet signal and accumulated flow parameters for the at least one mobile phase transition front. The height equivalent theoretical plate (HETP) value is calculated for the at least one mobile phase transition front using parameters of the model gamma cumulative distribution curve and the quality of the chromatography column packing is assessed based on the calculated HETP value. If during routine column monitoring, an adverse trend in HETP is observed or the control limits are exceeded, the eluate product quality, column process performance, and/or impurity removal data should be evaluated to ensure product quality for the identified batch. Should any of the product quality or column performance fail the criteria set, appropriate corrective action, such as conditioning, repacking or replacing the column, and qualification should be performed prior to release for further use.

2. 发明公开

EP3781943A1 CHROMATOGRAPHY COLUMN QUALIFICATION IN MANUFACTURING METHODS FOR PRODUCING ANTI-IL12/IL23 ANTIBODY COMPOSITIONS 有权
公开(公告)号：EP3781943A1
公开(公告)日：2021-02-24
申请号：EP19722993.3
申请日：2019-04-19
申请人： Janssen Biotech, Inc.
发明人： RANDOLPH, Paul
IPC分类号： G01N30/86 , G01N30/88 , C07K16/24 , G01N30/89

3. 发明公开

EP3781942A1 TRANSITION ANALYSIS METHOD FOR CHROMATOGRAPHY COLUMN QUALIFICATION 有权
公开(公告)号：EP3781942A1
公开(公告)日：2021-02-24
申请号：EP19722418.1
申请日：2019-04-19
申请人： Janssen Biotech, Inc.
发明人： RANDOLPH, Paul
IPC分类号： G01N30/86 , G01N30/88 , C07K16/24 , A61K38/00 , G01N30/56

4. 发明公开

EP3781941A1 CHROMATOGRAPHY COLUMN QUALIFICATION IN MANUFACTURING METHODS FOR PRODURING ANTI-TNF ANTIBODY COMPOSITIONS 审中-公开
公开(公告)号：EP3781941A1
公开(公告)日：2021-02-24
申请号：EP19722413.2
申请日：2019-04-19
申请人： Janssen Biotech, Inc.
发明人： RANDOLPH, Paul
IPC分类号： G01N30/86 , G01N30/88 , C07K16/24 , A61K38/00 , G01N30/56

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