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公开(公告)号：US11079361B2
公开(公告)日：2021-08-03
申请号：US16389114
申请日：2019-04-19
发明人： Paul Randolph
IPC分类号： G01N30/56 , C07K16/24 , G01N30/86 , B01D15/20 , B01D15/36 , B01D15/38 , C07K1/18 , C07K1/22 , B01D15/16 , G01N35/00
摘要： A method of operating a chromatography column is described for use in methods of manufacture for producing anti-IL-12/IL-23p40 antibodies, e.g., the anti-IL-12/IL-23p40 antibody STELARA® (ustekinumab). 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 calculated based on the collected column outlet signal and accumulated flow parameters for the at least one mobile phase transition front. A 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.
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公开(公告)号：US20220089716A1
公开(公告)日：2022-03-24
申请号：US17545128
申请日：2021-12-08
发明人： Paul Randolph
IPC分类号： C07K16/24 , G01N30/56 , G01N30/86 , B01D15/20 , B01D15/36 , B01D15/38 , C07K1/18 , C07K1/22 , B01D15/16 , G01N35/00
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.
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3.发明申请公开(公告)号：US20190322736A1
公开(公告)日：2019-10-24
申请号：US16389114
申请日：2019-04-19
发明人： Paul Randolph
摘要： A method of operating a chromatography column is described for use in methods of manufacture for producing anti-IL-12/IL-23p40 antibodies, e.g., the anti-IL-12/IL-23p40 antibody STELARA® (ustekinumab). 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 calculated based on the collected column outlet signal and accumulated flow parameters for the at least one mobile phase transition front. A 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.
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公开(公告)号：US20190321752A1
公开(公告)日：2019-10-24
申请号：US16389146
申请日：2019-04-19
发明人： Paul Randolph
摘要： A method of operating a chromatography column is described. 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 calculated based on the collected column outlet signal and accumulated flow parameters for the at least one mobile phase transition front. A 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.
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公开(公告)号：US12018075B2
公开(公告)日：2024-06-25
申请号：US16389055
申请日：2019-04-19
发明人： Paul Randolph
IPC分类号： C07K16/24 , B01D15/16 , B01D15/20 , B01D15/36 , B01D15/38 , C07K1/18 , C07K1/22 , G01N30/56 , G01N30/86 , G01N35/00
CPC分类号： C07K16/244 , B01D15/166 , B01D15/20 , B01D15/206 , B01D15/362 , B01D15/363 , B01D15/3809 , C07K1/18 , C07K1/22 , C07K16/241 , G01N30/56 , G01N30/8665 , G01N35/00623 , C07K2317/24 , C07K2317/31 , C07K2317/565 , G01N2030/562
摘要： A method of operating a chromatography column is described for use in methods of manufacture for producing anti-TNF antibodies, e.g., the anti-TNFα antibody SIMPONI® (golimumab). 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 calculated based on the collected column outlet signal and accumulated flow parameters for the at least one mobile phase transition front. A 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.
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公开(公告)号：US20210332124A1
公开(公告)日：2021-10-28
申请号：US17366360
申请日：2021-07-02
发明人： Paul Randolph
IPC分类号： C07K16/24 , C07K1/18 , B01D15/36 , B01D15/20 , C07K1/22 , G01N30/86 , G01N30/56 , B01D15/38 , B01D15/16 , G01N35/00
摘要： The present disclosure is directed to a method of operating a chromatography column in methods of manufacture for producing anti-IL-12/IL-23p40 antibodies, e.g., the anti-IL-12/IL-23p40 antibody STELARA® (ustekinumab), specific pharmaceutical compositions of the antibodies, and antigen binding fragments thereof. 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.
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公开(公告)号：US11225516B2
公开(公告)日：2022-01-18
申请号：US16389146
申请日：2019-04-19
发明人： Paul Randolph
IPC分类号： C07K16/24 , G01N30/56 , G01N30/86 , B01D15/20 , B01D15/36 , B01D15/38 , C07K1/18 , C07K1/22 , B01D15/16 , G01N35/00
摘要： A method of operating a chromatography column is described. 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 calculated based on the collected column outlet signal and accumulated flow parameters for the at least one mobile phase transition front. A 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.
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8.发明申请公开(公告)号：US20190324000A1
公开(公告)日：2019-10-24
申请号：US16389055
申请日：2019-04-19
发明人： Paul Randolph
摘要： A method of operating a chromatography column is described for use in methods of manufacture for producing anti-TNF antibodies, e.g., the anti-TNFα antibody SIMPONI® (golimumab). 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 calculated based on the collected column outlet signal and accumulated flow parameters for the at least one mobile phase transition front. A 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.
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