公开(公告)号：WO2021211550A1

公开(公告)日：2021-10-21

申请号：PCT/US2021/027043

申请日：2021-04-13

Applicant: REGENERON PHARMACEUTICALS, INC.

Inventor： SHIERLY, Eric ,  BRENNAN, Kevin ,  MAO, Nathan

IPC: G01N30/86 ,  G01N30/88

Abstract: Disclosed are methods for monitoring column chromatography performance. The methods can include acquiring one or more chromatogram ultraviolet (UV) traces generated by a chromatography system during sample purification and/or separation; and analyzing the one or more acquired chromatogram UV traces with an orthogonal partial least squares (OPLS) model, thereby allowing detection of column deterioration prior to column failure and quantitative analysis of UV signal in the one or more chromatogram UV traces.

公开(公告)号：WO2019079159A1

公开(公告)日：2019-04-25

申请号：PCT/US2018/055827

申请日：2018-10-15

Applicant: REGENERON PHARMACEUTICALS, INC.

Inventor： MAO, Nathan ,  SHIERLY, Eric ,  GALLEA, Joseph ,  FENG, Raymond ,  DISSANAYAKE, Tikiri ,  SCHILLING, Bernhard ,  CARVER, Scott

IPC: B01D15/20 ,  G01N30/56 ,  G01F23/292

Abstract: The present invention relates to methods for determining a slurry concentration for a slurry of a chromatography resin during a column packing. The present invention provides a more accurate and consistent method for determining a slurry concentration for packing a chromatography column. The method of the present invention utilizes an automated pump to provide a controlled flow rate to consolidate a resin sample. Based on the consolidated resin, a slurry concentration can be determined. The determined slurry concentration can be utilized to pack the resin in a chromatography column with highly accurate bed heights.

公开(公告)号：WO2019212881A1

公开(公告)日：2019-11-07

申请号：PCT/US2019/029268

申请日：2019-04-26

Applicant: REGENERON PHARMACEUTICALS, INC.

Inventor： MAO, Nathan ,  CRUZ, Annamarie ,  SCHILLING, Bernhard ,  CARVER, Scott

IPC: B01D15/38 ,  G01N33/538

Abstract: Embodiments of the present disclosure include methods and systems for detecting the presence of endotoxins in filters. For example, embodiments of the present disclosure are directed to methods and systems for improving in-process controls by detecting undesirable quantities of endotoxins in filters containing naturally-sourced materials prior to using those filters in the production of formulated drug substances.

公开(公告)号：WO2018081203A1

公开(公告)日：2018-05-03

申请号：PCT/US2017/058190

申请日：2017-10-25

Applicant: REGENERON PHARMACEUTICALS, INC.

Inventor： MAO, Nathan ,  SHIERLY, Eric ,  SCHILLING, Bernhard ,  CARVER, Scott ,  MCDERMOTT, Stefanie ,  MATTILA, John ,  BAK, Hanne

IPC: G01N30/86 ,  G01N30/88

Abstract: Embodiments of the present disclosure are directed to methods and systems for assessing integrity of chromatography columns, systems, and processes. The methods and systems can comprise one or more of extracting a block and signal combination for analysis, performing a transition analysis, performing one or more statistical process controls, and/or implementing in-process controls based on the statistical process controls.

Abstract translation: 本公开的实施例涉及用于评估色谱柱，系统和过程的完整性的方法和系统。 该方法和系统可以包括提取用于分析的块和信号组合，执行转换分析，执行一个或多个统计过程控制，和/或基于统计过程控制实施过程中控制中的一个或多个。