4.5 Article

Universal protocol and standard-spiking strategy for profiling of host cell proteins in therapeutic growth hormone

相关参考文献

注意:仅列出部分参考文献,下载原文获取全部文献信息。
Article Biochemical Research Methods

Optimized Sample Preparation and Data Processing of Data-Independent Acquisition Methods for the Robust Quantification of Trace-Level Host Cell Protein Impurities in Antibody Drug Products

Nicolas Pythoud et al.

Summary: Host cell proteins (HCPs) are important impurities in biopharmaceutical products, with monitoring being a critical quality attribute for monoclonal antibody (mAb) formulations. Mass spectrometry (MS) methods are emerging as powerful alternatives for HCP detection. This study developed an MS-based workflow for accurate quantification of major HCPs and measured the global HCP concentration in mAb samples. The approach proved to be reliable and sensitive, making it suitable for routine quality control in drug product analysis.

JOURNAL OF PROTEOME RESEARCH (2021)

Article Chemistry, Analytical

Simple and Sensitive Method for Deep Profiling of Host Cell Proteins in Therapeutic Antibodies by Combining Ultra-Low Trypsin Concentration Digestion, Long Chromatographic Gradients, and BoxCar Mass Spectrometry Acquisition

Song Nie et al.

Summary: LC-MS is a powerful tool for analyzing host cell proteins during antibody drug development, but the dynamic range between therapeutic antibodies and HCPs poses challenges. The ULTLB method enables sensitive and simple analysis of numerous HCPs without the need for cumbersome enrichment steps.

ANALYTICAL CHEMISTRY (2021)

Article Biochemistry & Molecular Biology

Targeted Capture of Chinese Hamster Ovary Host Cell Proteins: Peptide Ligand Discovery

R. Ashton Lavoie et al.

INTERNATIONAL JOURNAL OF MOLECULAR SCIENCES (2019)

Article Chemistry, Analytical

A Novel Sample Preparation for Shotgun Proteomics Characterization of HCPs in Antibodies

Lihua Huang et al.

ANALYTICAL CHEMISTRY (2017)

Article Biotechnology & Applied Microbiology

Host cell proteins in biotechnology-derived products: A risk assessment framework

Christina L. Zuch de Zafra et al.

BIOTECHNOLOGY AND BIOENGINEERING (2015)

Review Biotechnology & Applied Microbiology

Host Cell Protein Testing by ELISAs and the Use of Orthogonal Methods

Judith Zhu-Shimoni et al.

BIOTECHNOLOGY AND BIOENGINEERING (2014)

Review Biochemical Research Methods

Host cell protein analysis in therapeutic protein bioprocessing - methods and applications

Anne Luise Tscheliessnig et al.

BIOTECHNOLOGY JOURNAL (2013)

Article Biotechnology & Applied Microbiology

Demonstration of robust host cell protein clearance in biopharmaceutical downstream processes

Abhinav A. Shukla et al.

BIOTECHNOLOGY PROGRESS (2008)

Article Chemistry, Analytical

Analysis for residual host cell proteins and DNA in process streams of a recombinant protein product expressed in Escherichia coli cells

AS Rathore et al.

JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS (2003)