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Daniel Bracewell
Biotechnology and bioengineering, 2015
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Host cell protein testing by ELISAs and the use of orthogonal methods
Martin Vanderlaan
Biotechnology and Bioengineering, 2014
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A Comprehensive Approach for HCP Identification , Quantification , and Monitoring Based on a Single Dimension ( 1 D ) LC Separation
Ian Morns
2018
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Identification and Monitoring of Host Cell Proteins by Mass Spectrometry Combined with High Performance Immunochemistry Testing
Dietmar Reusch
PLoS ONE, 2013
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A novel approach to evaluate ELISA antibody coverage of host cell proteins—combining ELISA‐based immunocapture and mass spectrometry
Lars Skriver
Biotechnology Progress
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Enhanced Detection of Low-Abundance Host Cell Protein Impurities in High-Purity Monoclonal Antibodies Down to 1 ppm Using Ion Mobility Mass Spectrometry Coupled with Multidimensional Liquid Chromatography
Matthew Lauber
Analytical Chemistry, 2015
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Measurement of impurities to support process development and manufacture of biopharmaceuticals
Daniel Bracewell
TrAC Trends in Analytical Chemistry, 2018
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Fast, Robust, and Sensitive Identification of Residual Host Cell Proteins in Recombinant Monoclonal Antibodies Using Sodium Deoxycholate Assisted Digestion
Frank Macchi
Analytical Chemistry, 2020
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An enzyme-linked immunosorbent assay for host cell protein contaminants in recombinant PEGylated staphylokinase mutant SY161
Randall Moreadith
Journal of Pharmaceutical and Biomedical Analysis, 2002
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The challenges of product- and process-related impurities to an evolving biopharmaceutical industry
Daniel Bracewell
Bioanalysis, 2013
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Improved HCP Quantitation By Minimizing Antibody Cross-Reactivity to Target Proteins
Ned Mozier
2010
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Dual Data-Independent Acquisition Approach Combining Global HCP Profiling and Absolute Quantification of Key Impurities during Bioprocess Development
Daniel Bracewell
Analytical Chemistry, 2017
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Rapid characterization of biotherapeutic proteins by size-exclusion chromatography coupled to native mass spectrometry
Dietmar Reusch
mAbs, 2015
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A modular and adaptive mass spectrometry-based platform for support of bioprocess development toward optimal host cell protein clearance
David Michels
mAbs
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Comparison of Purification Strategies for Antibodies Used in a Broad Spectrum Host Cell Protein Immunoassay
Ned Mozier
Biotechnology and bioengineering, 2017
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Identification and Classification of Host Cell Proteins During Biopharmaceutical Process Development
Daniel Bracewell
Biotechnology Progress, 2021
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Improved Identification and Quantification of Host Cell Proteins (HCPs) in Biotherapeutics Using Liquid Chromatography-Mass Spectrometry
Matthew Lauber
ACS Symposium Series, 2015
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Host cell protein platform assay development for therapeutic mAb bioprocessing using mammalian cells
Laetitia Malphettes
BMC Proceedings, 2015
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Recommendations for the validation of immunoassays used for detection of host antibodies against biotechnology products
Mauricio Maia
Journal of pharmaceutical and biomedical analysis, 2008
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A 2D LC-MS/MS Strategy for Reliable Detection of 10-ppm Level Residual Host Cell Proteins in Therapeutic Antibodies
David Michels
Analytical Chemistry, 2018
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Quality Control of Widely Used Therapeutic Recombinant Proteins by a Novel Real-Time PCR Approach
Dariush Ilghari
Iranian biomedical journal, 2015
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Monoclonal Antibody Aggregate Polish and Viral Clearance Using Hydrophobic Interaction Chromatography
John Li
2019
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The measurement and control of high-risk host cell proteins for polysorbate degradation in biologics formulation
David Roush
Antibody Therapeutics, 2022
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Basic Principles and Applied GxP Regulations for ELISA Analytical Method Validation of Drugs and Biologics in FDA Driven Environment
Texila International Journal
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Quantitative impurity analysis of monoclonal antibody size heterogeneity by CE-LIF: Example of development and validation through a quality-by-design framework
David Michels
ELECTROPHORESIS, 2012
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Recommendations for the design and optimization of immunoassays used in the detection of host antibodies against biotechnology products
Gopi Gopi
Journal of …, 2004
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The dynamics of the CHO host cell protein profile during clarification and protein A capture in a platform antibody purification process
Daniel Bracewell
Biotechnology and Bioengineering, 2013
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A Novel Immunoaffinity Chromatography System for the Purification of Therapeutic Proteins
Peter Grandics
Annals of the New York Academy of Sciences, 1990
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Determination of immunogenic proteins in biopharmaceuticals by UHPLC–MS amino acid analysis
Jaroslav Galba
BMC Chemistry
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A Tiered Approach for Characterization to Ensure Quality, Reproducibility, and Long-Term Stability of Critical Reagents in Regulated Bioanalysis to Support PK/ADA/NAb Assays for Biologics and Vaccines Programs
LAI KUEN AU YEUNG
ACS Pharmacology & Translational Science, 2020
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Current challenges for FDA-regulated bioanalytical laboratories for human (BA/BE) studies, Part II: recent FDA Inspection trends for bioanalytical laboratories using LC/MS/MS methods and FDA Inspection readiness preparation
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The Quality Assurance Journal, 2007
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Very fast analysis of impurities in immunoglobulin concentrates using conjoint liquid chromatography on short monolithic disks
Miloš Barut
Journal of Immunological Methods, 2002
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Enzyme-linked immunosorbent assays (ELISAs) for the determination of contaminants resulting from the immunoaffinity purification of recombinant proteins
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Journal of Immunological Methods, 1988
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Plasma preparation to measure FDA-approved protein markers by selected reaction monitoring
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Clinical and Translational Medicine, 2015
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