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公开(公告)号：US20230279046A1
公开(公告)日：2023-09-07
申请号：US18114047
申请日：2023-02-24
Applicant: Regeneron Pharmaceuticals, Inc.
Inventor： Hui Xiao , Ning Li , Bo Zhao , Haruna Tomono , Mengqi Hu , Rosalynn Molden , Yunli Hu , Yu Huang , Haibo Qiu
Abstract: The present invention generally pertains to methods of identifying and characterizing host cell proteins. In particular, the present invention pertains to the use of size exclusion chromatography in non-denaturing or denaturing conditions to enrich a sample for host cell proteins and characterize the binding of host cell proteins to a protein of interest.
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公开(公告)号：US20230166199A1
公开(公告)日：2023-06-01
申请号：US17948496
申请日：2022-09-20
Applicant: Regeneron Pharmaceuticals, Inc.
Inventor： Xiaojing Zheng , Reid O'Brien Johnson , Tyler Greer , Mengqi Hu , Rosalynn Molden , Yunli Hu , Yu Huang , Haibo Qiu , Ning Li
CPC classification number: B01D15/1871 , B01D15/24 , B01D15/3809 , G01N30/7233 , G01N30/88 , G01N33/6848
Abstract: Methods for characterizing host-cell proteins in a sample matrix are provided.
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公开(公告)号：US20240418730A1
公开(公告)日：2024-12-19
申请号：US18745346
申请日：2024-06-17
Applicant: Regeneron Pharmaceuticals, Inc.
IPC: G01N33/68 , G01N33/569
Abstract: The present invention provides methods for identifying, quantifying, and/or characterizing at least one host cell protein (HCP) impurity in a sample containing AAV vectors. The HCP impurities can be enriched through a differential digestion, maintaining intact capsids while exposing the sample to mild denaturation. The mildly denatured sample can subsequently be subjected to enzymatic digestion, generating peptides which can be identified and quantified by liquid chromatography-mass spectrometry (LC-MS) analysis to identify, quantify and/or characterize said at least one HCP impurity.
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公开(公告)号：US20230408527A1
公开(公告)日：2023-12-21
申请号：US18208394
申请日：2023-06-12
Applicant: Regeneron Pharmaceuticals, Inc.
Inventor： Sook Yen E , Yunli Hu , Rosalynn Molden , Haibo Qiu , Ning Li
CPC classification number: G01N33/6848 , G01N30/7233 , G01N33/6845 , G01N2560/00
Abstract: A practical and effective method for low abundance host cell protein (HCP) identification and quantification, which facilitates the downstream purification process in eliminating potentially problematic HCPs. In particular, the method comprises performing a native digestion followed by characterization using Multiple Reaction Monitoring approach.
