Citations (141)
Keep up to date with the latest research on this topic with citation updates for this article.
Read on this site (10)
Elizabeth Sara Hecht, Shrenik Mehta, Aaron T. Wecksler, Ben Aguilar, Nathaniel Swanson, Wilson Phung, Ananya Dubey Kelsoe, W. Henry Benner, Devin Tesar, Robert F. Kelley, Wendy Sandoval & Alavattam Sreedhara. (2022) Insights into ultra-low affinity lipase-antibody noncovalent complex binding mechanisms. mAbs 14:1.
Read now
Read now
Ujwal Patil, Atul Goyal, Binh Vu, Yanyun Liu, Vijay Maranholkar, Katerina Kourentzi, James M. Briggs & Richard C. Willson. (2021) Antibody mix-and-read assays based on fluorescence intensity probes. mAbs 13:1.
Read now
Read now
Deepali Rathore, Anneliese Faustino, John Schiel, Eric Pang, Michael Boyne & Sarah Rogstad. (2018) The role of mass spectrometry in the characterization of biologic protein products. Expert Review of Proteomics 15:5, pages 431-449.
Read now
Read now
Xue Li, Feng Shi, Liping Gong, Baojian Hang, Daoyuan Li & Lianli Chi. (2017) Species-specific identification of collagen components in Colla corii asini using a nano-liquid chromatography tandem mass spectrometry proteomics approach. International Journal of Nanomedicine 12, pages 4443-4454.
Read now
Read now
Scott M. Henry, Elissa Sutlief, Oscar Salas-Solano & John Valliere-Douglass. (2017) ELISA reagent coverage evaluation by affinity purification tandem mass spectrometry. mAbs 9:7, pages 1065-1075.
Read now
Read now
Donald E. Walker, Feng Yang, Joseph Carver, Koman Joe, David A. Michels & X. Christopher Yu. (2017) A modular and adaptive mass spectrometry-based platform for support of bioprocess development toward optimal host cell protein clearance. mAbs 9:4, pages 654-663.
Read now
Read now
Robert E Birdsall, Henry Shion, Frank W Kotch, April Xu, Thomas J Porter & Weibin Chen. (2015) A rapid on-line method for mass spectrometric confirmation of a cysteine-conjugated antibody-drug-conjugate structure using multidimensional chromatography. mAbs 7:6, pages 1036-1044.
Read now
Read now
James A Madsen, Victor Farutin, Theresa Carbeau, Steve Wudyka, Yan Yin, Stephen Smith, James Anderson & Ishan Capila. (2015) Toward the complete characterization of host cell proteins in biotherapeutics via affinity depletions, LC-MS/MS, and multivariate analysis. mAbs 7:6, pages 1128-1137.
Read now
Read now
Qingchun Zhang, Andrew M Goetze, Huanchun Cui, Jenna Wylie, Steve Trimble, Art Hewig & Gregory C Flynn. (2014) Comprehensive tracking of host cell proteins during monoclonal antibody purifications using mass spectrometry. mAbs 6:3, pages 659-670.
Read now
Read now
R. Jeremy Woods, Michael Hongwei Xie, Thomas Spreter Von Kreudenstein, Gordon Y. Ng & Surjit B. Dixit. (2013) LC-MS characterization and purity assessment of a prototype bispecific antibody. mAbs 5:5, pages 711-722.
Read now
Read now
Articles from other publishers (131)
Sarfaraz K. Niazi. (2023) A Critical Analysis of the FDA’s Omics-Driven Pharmacodynamic Biomarkers to Establish Biosimilarity. Pharmaceuticals 16:11, pages 1556.
Crossref
Crossref
Dnyandeo Pawar, Daniela Lo Presti, Sergio Silvestri, Emiliano Schena & Carlo Massaroni. (2023) Current and future technologies for monitoring cultured meat: A review. Food Research International 173, pages 113464.
Crossref
Crossref
Young Hoon Oh, Kerri M. Mendola, Leila H. Choe, Lie Min, Ashton R. Lavoie, Sobhana A. Sripada, Taufika Islam Williams, Kelvin H. Lee, Yinges Yigzaw, Alexander Seay, Jerome Bill, Xuanwen Li, David J. Roush, Steven M. Cramer, Stefano Menegatti & Abraham M. Lenhoff. (2023) Identification and characterization of CHO host‐cell proteins in monoclonal antibody bioprocessing. Biotechnology and Bioengineering.
Crossref
Crossref
Xuanwen Li. (2023) Recent applications of quantitative mass spectrometry in biopharmaceutical process development and manufacturing. Journal of Pharmaceutical and Biomedical Analysis 234, pages 115581.
Crossref
Crossref
Corentin Beaumal, Alain Beck, Oscar Hernandez‐Alba & Christine Carapito. (2023) Advanced mass spectrometry workflows for accurate quantification of trace‐level host cell proteins in drug products: Benefits of FAIMS separation and gas‐phase fractionation DIA. PROTEOMICS 23:16.
Crossref
Crossref
Zhouyi Wu, Gangling Xu, Wu He, Chuanfei Yu, Wanqiu Huang, Shirui Zheng, Dian Kang, Michael H Xie, Xingjun Cao, Lan Wang & Kaikun Wei. (2023) Comparability strategy and demonstration for post-approval production cell line change of a bevacizumab biosimilar IBI305. Antibody Therapeutics 6:3, pages 194-210.
Crossref
Crossref
Somar Khalil, Adeline Wychowski, Cyrille Chéry & Annick Gervais. (2023) Label-free shotgun proteomics: Exploiting a reliable and sensitive method to monitor residual host-cell proteins in monoclonal antibody products. Journal of Pharmaceutical and Biomedical Analysis Open 1, pages 100012.
Crossref
Crossref
Feng Liu, Weicheng Ren, Hailong Liu, Hao Liu, Shuyue Wang, Di Zhang, Dandan Sun, Feifei Zhang, Zhengkang Shao, Jia Feng, Menghan Yan, Lan Yang, Zhiwei Wang, Jinliang Zhang & Yingwu Wang. (2023) Universal protocol and standard-spiking strategy for profiling of host cell proteins in therapeutic growth hormone. Analytical Biochemistry 670, pages 115136.
Crossref
Crossref
Steve Hessmann, Cyrille Chery, Anne-Sophie Sikora, Annick Gervais & Christine Carapito. (2023) Host cell protein quantification workflow using optimized standards combined with data-independent acquisition mass spectrometry. Journal of Pharmaceutical Analysis 13:5, pages 494-502.
Crossref
Crossref
Qinqin Ji, Izabela Sokolowska, Rui Cao, Yulei Jiang, Jingjie Mo & Ping Hu. (2023) A highly sensitive and robust LC-MS platform for host cell protein characterization in biotherapeutics. Biologicals 82, pages 101675.
Crossref
Crossref
Shunsuke Takagi, Masayoshi Shibata, Nobuyuki Suzuki & Yasushi Ishihama. (2022) Immunoreactivity profiling of Anti-Chinese hamster ovarian host cell protein antibodies by isobaric labeled affinity purification-mass spectrometry reveals low-recovery proteins. Journal of Chromatography A 1685, pages 463645.
Crossref
Crossref
Dorothy M. Kim, Kensey Stansberry-Perkins, Michael S. Marlow & Erica A. Pyles. (2022) Human Serum Albumin Mitigates Formation of Fatty Acid Particles in Polysorbate-Containing Solutions. Journal of Pharmaceutical Sciences 111:11, pages 3185-3188.
Crossref
Crossref
Viki Chopda, Aron Gyorgypal, Ou Yang, Ravendra Singh, Rohit Ramachandran, Haoran Zhang, George Tsilomelekis, Shishir P S Chundawat & Marianthi G Ierapetritou. (2021) Recent advances in integrated process analytical techniques, modeling, and control strategies to enable continuous biomanufacturing of monoclonal antibodies. Journal of Chemical Technology & Biotechnology 97:9, pages 2317-2335.
Crossref
Crossref
Gao-Yuan Liu, Song Nie, Xiaojing Zheng & Ning Li. (2022) Activity-Based Protein Profiling Probe for the Detection of Enzymes Catalyzing Polysorbate Degradation. Analytical Chemistry 94:24, pages 8625-8632.
Crossref
Crossref
Christina Seisenberger, Tobias Graf, Markus Haindl, Harald Wegele, Michael Wiedmann & Stefanie Wohlrab. (2022)
Toward optimal clearance: A universal affinity‐based mass spectrometry approach for comprehensive
ELISA
reagent coverage evaluation and
HCP
hitchhiker analysis
. Biotechnology Progress 38:3.
Crossref
Crossref
Solomon Isu, Xianghong Qian, Andrew L. Zydney & S. Ranil Wickramasinghe. (2022) Process- and Product-Related Foulants in Virus Filtration. Bioengineering 9:4, pages 155.
Crossref
Crossref
Evan Wright, Karina Kawka, Maria Fe C. Medina & David R. Latulippe. (2022) Evaluation of Host Cell Impurity Effects on the Performance of Sterile Filtration Processes for Therapeutic Viruses. Membranes 12:4, pages 359.
Crossref
Crossref
Katrine Pilely, Martin Rask Johansen, Rikke Raaen Lund, Thomas Kofoed, Thomas Kjærsgaard Jørgensen, Lars Skriver & Ejvind Mørtz. (2021) Monitoring process-related impurities in biologics–host cell protein analysis. Analytical and Bioanalytical Chemistry 414:2, pages 747-758.
Crossref
Crossref
Feng Yang, Delia Li & Donald E. Walker. 2022. Therapeutic Antibodies. Therapeutic Antibodies
269
279
.
Lisa Strasser, Giorgio Oliviero, Craig Jakes, Izabela Zaborowska, Patrick Floris, Meire Ribeiro da Silva, Florian Füssl, Sara Carillo & Jonathan Bones. (2021) Detection and quantitation of host cell proteins in monoclonal antibody drug products using automated sample preparation and data-independent acquisition LC-MS/MS. Journal of Pharmaceutical Analysis 11:6, pages 726-731.
Crossref
Crossref
Kirsty Skeene, Kshitij Khatri, Zoja Soloviev & Cris Lapthorn. (2021) Current status and future prospects for ion-mobility mass spectrometry in the biopharmaceutical industry. Biochimica et Biophysica Acta (BBA) - Proteins and Proteomics 1869:12, pages 140697.
Crossref
Crossref
Dirk-H. Evers, Stefan Carle, Daniel Lakatos, Frank Hämmerling, Patrick Garidel & Julia Buske. (2021) Hydrolytic polysorbate 20 degradation – Sensitive detection of free fatty acids in biopharmaceuticals via UPLC-QDa analytics with isolator column. Journal of Chromatography B 1174, pages 122717.
Crossref
Crossref
Donald J. AbrahamYao‐ming Huang, Brian Bowes, Tzung‐Horng Yang, James N. Thomas, S. Sam Guhan & Dean K. Pettit. 2003. Burger's Medicinal Chemistry and Drug Discovery. Burger's Medicinal Chemistry and Drug Discovery
1
68
.
Song Nie, Tyler Greer, Reid O’Brien Johnson, Xiaojing Zheng, Albert Torri & Ning Li. (2021) 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. Analytical Chemistry 93:10, pages 4383-4390.
Crossref
Crossref
Yi Wen & Vibha Jawa. (2021) The Impact of Product and Process Related Critical Quality Attributes on Immunogenicity and Adverse Immunological Effects of Biotherapeutics. Journal of Pharmaceutical Sciences 110:3, pages 1025-1041.
Crossref
Crossref
Yvonne Ehwang Song, Hervé Dubois, Martin Hoffmann, Stephen D́Eri, Yann Fromentin, Jan Wiesner, Anja Pfenninger, Séverine Clavier, Annette Pieper, Laurent Duhau & Udo Roth. (2021) Automated mass spectrometry multi-attribute method analyses for process development and characterization of mAbs. Journal of Chromatography B 1166, pages 122540.
Crossref
Crossref
Mathieu Trauchessec, Anne Marie Hesse, Alexandra Kraut, Yves Berard, Laura Herment, Tanguy Fortin, Christophe Bruley, Myriam Ferro & Catherine Manin. (2021) An innovative standard for LC‐MS‐based HCP profiling and accurate quantity assessment: Application to batch consistency in viral vaccine samples. PROTEOMICS 21:5.
Crossref
Crossref
Ramesh Kumar, Rohan L. Shah, Shadab Ahmad & Anurag S. Rathore. (2021) Harnessing the power of electrophoresis and chromatography: Offline coupling of reverse phase liquid chromatography‐capillary zone electrophoresis‐tandem mass spectrometry for analysis of host cell proteins in monoclonal antibody producing CHO cell line. ELECTROPHORESIS 42:6, pages 735-741.
Crossref
Crossref
R. Ashton Lavoie, Wenning Chu, Joseph H. Lavoie, Zachary Hetzler, Taufika Islam Williams, Ruben Carbonell & Stefano Menegatti. (2021) Removal of host cell proteins from cell culture fluids by weak partitioning chromatography using peptide-based adsorbents. Separation and Purification Technology 257, pages 117890.
Crossref
Crossref
Nicolas Pythoud, Joanna Bons, Geoffroy Mijola, Alain Beck, Sarah Cianférani & Christine Carapito. (2020) 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. Journal of Proteome Research 20:1, pages 923-931.
Crossref
Crossref
Tobias Graf, Michael Leiss, Markus Haberger & Patrick Bulau. 2021. Monoclonal Antibodies. Monoclonal Antibodies
199
234
.
I-Hsuan Chen, Hui Xiao & Ning Li. (2020) Improved host cell protein analysis in monoclonal antibody products through ProteoMiner. Analytical Biochemistry 610, pages 113972.
Crossref
Crossref
Ujwal Patil, Mary Crum, Binh Vu, Katherine Wasden, Katerina Kourentzi & Richard C. Willson. (2020) Continuous Fc detection for protein A capture process control. Biosensors and Bioelectronics 165, pages 112327.
Crossref
Crossref
Delia Li, Adam Farchone, Qing Zhu, Frank Macchi, Donald E. Walker, David A. Michels & Feng Yang. (2020) Fast, Robust, and Sensitive Identification of Residual Host Cell Proteins in Recombinant Monoclonal Antibodies Using Sodium Deoxycholate Assisted Digestion. Analytical Chemistry 92:17, pages 11888-11894.
Crossref
Crossref
Wolfgang Esser-Skala, Marius Segl, Therese Wohlschlager, Veronika Reisinger, Johann Holzmann & Christian G. Huber. (2020) Exploring sample preparation and data evaluation strategies for enhanced identification of host cell proteins in drug products of therapeutic antibodies and Fc-fusion proteins. Analytical and Bioanalytical Chemistry 412:24, pages 6583-6593.
Crossref
Crossref
Reid O’Brien Johnson, Tyler Greer, Milos Cejkov, Xiaojing Zheng & Ning Li. (2020) Combination of FAIMS, Protein A Depletion, and Native Digest Conditions Enables Deep Proteomic Profiling of Host Cell Proteins in Monoclonal Antibodies. Analytical Chemistry 92:15, pages 10478-10484.
Crossref
Crossref
Qingyi Wang, Thomas R. Slaney, Wei Wu, Richard Ludwig, Li Tao & Anthony Leone. (2020) Enhancing Host-Cell Protein Detection in Protein Therapeutics Using HILIC Enrichment and Proteomic Analysis. Analytical Chemistry 92:15, pages 10327-10335.
Crossref
Crossref
Tobias Graf, Katrin Heinrich, Ingrid Grunert, Harald Wegele, Markus Haberger, Patrick Bulau & Michael Leiss. (2020) Recent advances in LC–MS based characterization of protein-based bio-therapeutics – mastering analytical challenges posed by the increasing format complexity. Journal of Pharmaceutical and Biomedical Analysis 186, pages 113251.
Crossref
Crossref
Katrine Pilely, Solveig B. Nielsen, Anette Draborg, Maiken L. Henriksen, Søren W. K. Hansen, Lars Skriver, Ejvind Mørtz & Rikke R. Lund. (2020) A novel approach to evaluate ELISA antibody coverage of host cell proteins—combining ELISA‐based immunocapture and mass spectrometry. Biotechnology Progress 36:4.
Crossref
Crossref
Harriet Mörtstedt, Åsa Makower, Per-Olof Edlund, Katarina Sjöberg & Agneta Tjernberg. (2020) Improved identification of host cell proteins in a protein biopharmaceutical by LC–MS/MS using the ProteoMiner™ Enrichment Kit. Journal of Pharmaceutical and Biomedical Analysis 185, pages 113256.
Crossref
Crossref
Xiaoran Roger Liu, Mengru Mira Zhang & Michael L. Gross. (2020) Mass Spectrometry-Based Protein Footprinting for Higher-Order Structure Analysis: Fundamentals and Applications. Chemical Reviews 120:10, pages 4355-4454.
Crossref
Crossref
I-Hsuan Chen, Hui Xiao, Thomas Daly & Ning Li. (2020) Improved Host Cell Protein Analysis in Monoclonal Antibody Products through Molecular Weight Cutoff Enrichment. Analytical Chemistry 92:5, pages 3751-3757.
Crossref
Crossref
Angela Tartaglia, Marcello Locatelli & Victoria Samanidou. (2020) Trends in the Analysis of Biopharmaceuticals by HPLC. Current Analytical Chemistry 16:1, pages 52-58.
Crossref
Crossref
Xinliu Gao, Baibhav Rawal, Yi Wang, Xuanwen Li, David Wylie, Yan-Hui Liu, Lloyd Breunig, Dennis Driscoll, Fengqiang Wang & Douglas D. Richardson. (2019) Targeted Host Cell Protein Quantification by LC–MRM Enables Biologics Processing and Product Characterization. Analytical Chemistry 92:1, pages 1007-1015.
Crossref
Crossref
Anna C. Robotham & John F. Kelly. 2020. Approaches to the Purification, Analysis and Characterization of Antibody-Based Therapeutics. Approaches to the Purification, Analysis and Characterization of Antibody-Based Therapeutics
1
33
.
Yuanzhong Yang, Khosse Mitri, Chunfang Zhang, Reinhard I. Boysen & Milton T.W. Hearn. (2019) Promiscuity of host cell proteins in the purification of histidine tagged recombinant xylanase A by IMAC procedures: A case study with a Ni2+-tacn-based IMAC system. Protein Expression and Purification 162, pages 51-61.
Crossref
Crossref
Regina Kufer, Markus Haindl, Harald Wegele & Stefanie Wohlrab. (2019) Evaluation of Peptide Fractionation and Native Digestion as Two Novel Sample Preparation Workflows to Improve HCP Characterization by LC–MS/MS. Analytical Chemistry 91:15, pages 9716-9723.
Crossref
Crossref
Swarnim Ranjan, Wai Keen Chung, Min Zhu, David Robbins & Steven M. Cramer. (2019) Implementation of an experimental and computational tool set to study protein‐mAb interactions. Biotechnology Progress 35:4.
Crossref
Crossref
Nobuo Fukuda, Yukako Senga & Shinya Honda. (2019)
Anxa2
‐ and
Ctsd
‐knockout CHO cell lines to diminish the risk of contamination with host cell proteins
. Biotechnology Progress 35:4.
Crossref
Crossref
Swarnim Ranjan, Wai Keen Chung, Romina Hofele, Jenny Heidbrink Thompson, Jared Bee, Limin Zhang, David Robbins & Steven M. Cramer. (2019) Investigation of cathepsin D–mAb interactions using a combined experimental and computational tool set. Biotechnology and Bioengineering 116:7, pages 1684-1697.
Crossref
Crossref
Jérémie Giorgetti, Antony Lechner, Elise Del Nero, Alain Beck, Yannis-Nicolas François & Emmanuelle Leize-Wagner. (2018) Intact monoclonal antibodies separation and analysis by sheathless capillary electrophoresis-mass spectrometry. European Journal of Mass Spectrometry 25:3, pages 324-332.
Crossref
Crossref
S. Gilgunn, H. El-Sabbahy, S. Albrecht, M. Gaikwad, K. Corrigan, L. Deakin, G. Jellum & J. Bones. (2019) Identification and tracking of problematic host cell proteins removed by a synthetic, highly functionalized nonwoven media in downstream bioprocessing of monoclonal antibodies. Journal of Chromatography A 1595, pages 28-38.
Crossref
Crossref
Cher H. Goey, David Bell & Cleo Kontoravdi. (2019) CHO cell cultures in shake flasks and bioreactors present different host cell protein profiles in the supernatant. Biochemical Engineering Journal 144, pages 185-192.
Crossref
Crossref
Shraddha S. Rane, Rebecca J. Dearman, Ian Kimber, Shahid Uddin, Stephen Bishop, Maryam Shah, Adrian Podmore, Alain Pluen & Jeremy P. Derrick. (2019) Impact of a Heat Shock Protein Impurity on the Immunogenicity of Biotherapeutic Monoclonal Antibodies. Pharmaceutical Research 36:4.
Crossref
Crossref
Sarah Gilgunn & Jonathan Bones. (2018) Challenges to industrial mAb bioprocessing—removal of host cell proteins in CHO cell bioprocesses. Current Opinion in Chemical Engineering 22, pages 98-106.
Crossref
Crossref
Feng Yang, Donald E. Walker, Jeannine Schoenfelder, Joseph Carver, Alice Zhang, Delia Li, Reed Harris, John T. Stults, X. Christopher Yu & David A. Michels. (2018) A 2D LC-MS/MS Strategy for Reliable Detection of 10-ppm Level Residual Host Cell Proteins in Therapeutic Antibodies. Analytical Chemistry 90:22, pages 13365-13372.
Crossref
Crossref
Viktor Háda, Attila Bagdi, Zsolt Bihari, Sarolta Baginé Timári, Ádám Fizil & Csaba SzántayJr.Jr.. (2018) Recent advancements, challenges, and practical considerations in the mass spectrometry-based analytics of protein biotherapeutics: A viewpoint from the biosimilar industry. Journal of Pharmaceutical and Biomedical Analysis 161, pages 214-238.
Crossref
Crossref
Kristin N Valente, Nicholas E Levy, Kelvin H Lee & Abraham M Lenhoff. (2018) Applications of proteomic methods for CHO host cell protein characterization in biopharmaceutical manufacturing. Current Opinion in Biotechnology 53, pages 144-150.
Crossref
Crossref
Farideh Haghighi, Zahra Talebpour & Amir Sanati Nezhad. (2018) Towards fully integrated liquid chromatography on a chip: Evolution and evaluation. TrAC Trends in Analytical Chemistry 105, pages 302-337.
Crossref
Crossref
Søren Heissel, Jakob Bunkenborg, Max Per Kristiansen, Anne Fich Holmbjerg, Marie Grimstrup, Ejvind Mørtz, Thomas Kofoed & Peter Højrup. (2018) Evaluation of spectral libraries and sample preparation for DIA-LC-MS analysis of host cell proteins: A case study of a bacterially expressed recombinant biopharmaceutical protein. Protein Expression and Purification 147, pages 69-77.
Crossref
Crossref
Cher Hui Goey, Sakhr Alhuthali & Cleo Kontoravdi. (2018) Host cell protein removal from biopharmaceutical preparations: Towards the implementation of quality by design. Biotechnology Advances 36:4, pages 1223-1237.
Crossref
Crossref
Simone Albrecht, Christian Kaisermayer, Clair Gallagher, Amy Farrell, Anna Lindeberg & Jonathan Bones. (2018) Proteomics in biomanufacturing control: Protein dynamics of CHO‐K1 cells and conditioned media during apoptosis and necrosis. Biotechnology and Bioengineering 115:6, pages 1509-1520.
Crossref
Crossref
Guillaume Chevreux, Nolwenn Tilly & Nicolas Bihoreau. (2018) Quantification of proteins by data independent acquisition: Performance assessment of the Hi3 methodology. Analytical Biochemistry 549, pages 184-187.
Crossref
Crossref
Simone Albrecht, Christian Kaisermayer, David Reinhart, Monica Ambrose, Renate Kunert, Anna Lindeberg & Jonathan Bones. (2018) Multiple reaction monitoring targeted LC-MS analysis of potential cell death marker proteins for increased bioprocess control. Analytical and Bioanalytical Chemistry 410:13, pages 3197-3207.
Crossref
Crossref
James B. McGivneyIVIV, Andrew T. Csordas, Faye M. Walker, Elizabeth R. Bagley, Emily M. Gruber, Peter L. Mage, Jose Casas-Finet, Margaret A. Nakamoto, Michael Eisenstein, Christopher J. Larkin, Robert J. Strouse & H. Tom Soh. (2018) Strategy for Generating Sequence-Defined Aptamer Reagent Sets for Detecting Protein Contaminants in Biotherapeutics. Analytical Chemistry 90:5, pages 3262-3269.
Crossref
Crossref
Gauthier Husson, Aurélie Delangle, John O’HaraSarah Cianferani, Annick Gervais, Alain Van Dorsselaer, Dan BracewellChristine Carapito. (2017) Dual Data-Independent Acquisition Approach Combining Global HCP Profiling and Absolute Quantification of Key Impurities during Bioprocess Development. Analytical Chemistry 90:2, pages 1241-1247.
Crossref
Crossref
Francesco Cacciola, Marina Russo, Luigi Mondello & Paola Dugo. 2018. Advances in the Use of Liquid Chromatography Mass Spectrometry (LC-MS) - Instrumentation Developments and Applications. Advances in the Use of Liquid Chromatography Mass Spectrometry (LC-MS) - Instrumentation Developments and Applications
81
123
.
Matthew J. Traylor, Peter Bernhardt, Bruce S. Tangarone & Johnson Varghese. 2018. Biopharmaceutical Processing. Biopharmaceutical Processing
1001
1049
.
Denise Krawitz, Jason C. Rouse, Justin B. Sperry, Wendy Sandoval & Martin Vanderlaan. 2017. Analytical Characterization of Biotherapeutics. Analytical Characterization of Biotherapeutics
211
237
.
Deepti Ahluwalia, Harbhajan Dhillon, Thomas Slaney, Hangtian Song, Heather Boux, Sheetal Mehta, Lei Zhang, Anulfo Valdez & Girija Krishnamurthy. (2017) Identification of a host cell protein impurity in therapeutic protein, P1. Journal of Pharmaceutical and Biomedical Analysis 141, pages 32-38.
Crossref
Crossref
Yifeng Li. (2017) Effective strategies for host cell protein clearance in downstream processing of monoclonal antibodies and Fc-fusion proteins. Protein Expression and Purification 134, pages 96-103.
Crossref
Crossref
Lihua Huang, Ning Wang, Charles E. Mitchell, Tammy Brownlee, Steven R. Maple & Michael R. De Felippis. (2017) A Novel Sample Preparation for Shotgun Proteomics Characterization of HCPs in Antibodies. Analytical Chemistry 89:10, pages 5436-5444.
Crossref
Crossref
Simion Kreimer, Yuanwei Gao, Somak Ray, Mi Jin, Zhijun Tan, Nesredin A. Mussa, Li Tao, Zhengjian Li, Alexander R. Ivanov & Barry L. Karger. (2017) Host Cell Protein Profiling by Targeted and Untargeted Analysis of Data Independent Acquisition Mass Spectrometry Data with Parallel Reaction Monitoring Verification. Analytical Chemistry 89:10, pages 5294-5302.
Crossref
Crossref
Damiano Migani, C. Mark Smales & Daniel G. Bracewell. (2017)
Effects of lysosomal biotherapeutic recombinant protein expression on cell stress and protease and general host cell protein release in
C
hinese hamster ovary cells
. Biotechnology Progress 33:3, pages 666-676.
Crossref
Crossref
Josephine Chiu, Kristin N. Valente, Nicholas E. Levy, Lie Min, Abraham M. Lenhoff & Kelvin H. Lee. (2016) Knockout of a difficult‐to‐remove CHO host cell protein, lipoprotein lipase, for improved polysorbate stability in monoclonal antibody formulations. Biotechnology and Bioengineering 114:5, pages 1006-1015.
Crossref
Crossref
Kirsty D. Ratanji, Jeremy P. Derrick, Ian Kimber, Robin Thorpe, Meenu Wadhwa & Rebecca J. Dearman. (2016)
Influence of
Escherichia coli
chaperone DnaK on protein immunogenicity
. Immunology 150:3, pages 343-355.
Crossref
Crossref
Abasha Williams, Erik K. Read, Cyrus D. Agarabi, Scott Lute & Kurt A. Brorson. (2017) Automated 2D-HPLC method for characterization of protein aggregation with in-line fraction collection device. Journal of Chromatography B 1046, pages 122-130.
Crossref
Crossref
Zhenbin Zhang, Thomas Albanetti, Travis Linkous, Christopher J. Larkin, Ronald Schoner, James B. McGivneyIVIV & Norman J Dovichi. (2017) Comprehensive analysis of host cell impurities in monoclonal antibodies with improved sensitivity by capillary zone electrophoresis mass spectrometry. ELECTROPHORESIS 38:3-4, pages 401-407.
Crossref
Crossref
Vibha Jawa, Marisa K. Joubert, Qingchun Zhang, Meghana Deshpande, Suminda Hapuarachchi, Michael P. Hall & Gregory C. Flynn. (2016) Evaluating Immunogenicity Risk Due to Host Cell Protein Impurities in Antibody-Based Biotherapeutics. The AAPS Journal 18:6, pages 1439-1452.
Crossref
Crossref
Dwight Stoll, John Danforth, Kelly Zhang & Alain Beck. (2016) Characterization of therapeutic antibodies and related products by two-dimensional liquid chromatography coupled with UV absorbance and mass spectrometric detection. Journal of Chromatography B 1032, pages 51-60.
Crossref
Crossref
Rabah Gahoual, Alain Beck, Emmanuelle Leize-Wagner & Yannis-Nicolas François. (2016) Cutting-edge capillary electrophoresis characterization of monoclonal antibodies and related products. Journal of Chromatography B 1032, pages 61-78.
Crossref
Crossref
Nicholas E. Levy, Kristin N. Valente, Kelvin H. Lee & Abraham M. Lenhoff. (2015) Host cell protein impurities in chromatographic polishing steps for monoclonal antibody purification. Biotechnology and Bioengineering 113:6, pages 1260-1272.
Crossref
Crossref
Qingchun Zhang, Andrew M. Goetze, Huanchun Cui, Jenna Wylie, Ben Tillotson, Art Hewig, Michael P. Hall & Gregory C. Flynn. (2016) Characterization of the co-elution of host cell proteins with monoclonal antibodies during protein A purification. Biotechnology Progress 32:3, pages 708-717.
Crossref
Crossref
Zulfaquar Ahmad Arfi, Stephan Hellwig, Jürgen Drossard, Rainer Fischer & Johannes Felix Buyel. (2016) Polyclonal antibodies for specific detection of tobacco host cell proteins can be efficiently generated following RuBisCO depletion and the removal of endotoxins. Biotechnology Journal 11:4, pages 507-518.
Crossref
Crossref
Catherine E.M. Hogwood, Shahina S. Ahmad, Richard D. Tarrant, Daniel G. Bracewell & C. Mark Smales. (2016) An ultra scale-down approach identifies host cell protein differences across a panel of mAb producing CHO cell line variants. Biotechnology Journal 11:3, pages 415-424.
Crossref
Crossref
Guijie Zhu, Liangliang Sun, Jennifer Heidbrink-Thompson, Srilatha Kuntumalla, Hung-yu Lin, Christopher J. Larkin, James B. McGivneyIVIV & Norman J. Dovichi. (2016) Capillary zone electrophoresis tandem mass spectrometry detects low concentration host cell impurities in monoclonal antibodies. ELECTROPHORESIS 37:4, pages 616-622.
Crossref
Crossref
Anurag S. Rathore, Sumit K. Singh, Neh Nupur & Gunjan Narula. 2016. Biomarker Discovery in the Developing World: Dissecting the Pipeline for Meeting the Challenges. Biomarker Discovery in the Developing World: Dissecting the Pipeline for Meeting the Challenges
83
97
.
Lichao Zhang. 2016. Capillary Electrophoresis-Mass Spectrometry. Capillary Electrophoresis-Mass Spectrometry
39
42
.
Dwight R Stoll. (2015) Recent advances in 2D-LC for bioanalysis. Bioanalysis 7:24, pages 3125-3142.
Crossref
Crossref
Koen Sandra & Pat Sandra. (2015) The opportunities of 2D-LC in the analysis of monoclonal antibodies. Bioanalysis 7:22, pages 2843-2847.
Crossref
Crossref
Catalin E. Doneanu, Malcolm AndersonBrad J. Williams, Matthew A. Lauber, Asish Chakraborty & Weibin Chen. (2015) 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. Analytical Chemistry 87:20, pages 10283-10291.
Crossref
Crossref
Inn H. Yuk, Julie Nishihara, Donald Walker Jr, Eric Huang, Feny Gunawan, Jayashree Subramanian, Abigail F.J. Pynn, X.Christopher Yu, Judith Zhu-Shimoni, Martin Vanderlaan & Denise C. Krawitz. (2015) More similar than different: Host cell protein production using three null CHO cell lines. Biotechnology and Bioengineering 112:10, pages 2068-2083.
Crossref
Crossref
Amy Farrell, Stefan Mittermayr, Brian Morrissey, Niaobh Mc Loughlin, Natalia Navas Iglesias, Ian W. Marison & Jonathan Bones. (2015)
Quantitative Host Cell Protein Analysis Using Two Dimensional Data Independent LC–MS
E
. Analytical Chemistry 87:18, pages 9186-9193.
Crossref
Crossref
Jared S. Bee, Liu Tie, Douglas Johnson, Mariana N. Dimitrova, Kristin C. Jusino & Christopher D. Afdahl. (2015) Trace levels of the CHO host cell protease cathepsin D caused particle formation in a monoclonal antibody product. Biotechnology Progress 31:5, pages 1360-1369.
Crossref
Crossref
Daniel G. Bracewell, Richard Francis & C. Mark Smales. (2015) The future of host cell protein (HCP) identification during process development and manufacturing linked to a risk‐based management for their control. Biotechnology and Bioengineering 112:9, pages 1727-1737.
Crossref
Crossref
Hong Wang & Sam Hanash. (2015) Mass spectrometry based proteomics for absolute quantification of proteins from tumor cells. Methods 81, pages 34-40.
Crossref
Crossref
Kristin N. Valente, Abraham M. Lenhoff & Kelvin H. Lee. (2015) Expression of difficult‐to‐remove host cell protein impurities during extended Chinese hamster ovary cell culture and their impact on continuous bioprocessing. Biotechnology and Bioengineering 112:6, pages 1232-1242.
Crossref
Crossref
Weibin Chen, Catalin E. Doneanu, Matthew Lauber, Stephan Koza, Kesh Prakash, Martha Stapels & Kenneth J. Fountain. 2015. State-of-the-Art and Emerging Technologies for Therapeutic Monoclonal Antibody Characterization Volume 3. Defining the Next Generation of Analytical and Biophysical Techniques. State-of-the-Art and Emerging Technologies for Therapeutic Monoclonal Antibody Characterization Volume 3. Defining the Next Generation of Analytical and Biophysical Techniques
357
393
.
Kesh Prakash & Weibin Chen. 2015. State-of-the-Art and Emerging Technologies for Therapeutic Monoclonal Antibody Characterization Volume 2. Biopharmaceutical Characterization: The NISTmAb Case Study. State-of-the-Art and Emerging Technologies for Therapeutic Monoclonal Antibody Characterization Volume 2. Biopharmaceutical Characterization: The NISTmAb Case Study
387
404
.
Dong Xu, Sarthak Mane & Zoran Sosic. (2015) Characterization of a biopharmaceutical protein and evaluation of its purification process using automated capillary Western blot. ELECTROPHORESIS 36:2, pages 363-370.
Crossref
Crossref
Robert G. Brinson, Gary G. Giulian, Zvi Kelman & John P. Marino. (2014) Detection of Contaminating Enzymatic Activity in Plant-Derived Recombinant Biotechnology Products. Analytical Chemistry 86:23, pages 11508-11512.
Crossref
Crossref
Daniel A.M. Pais, Manuel JT Carrondo, Paula M Alves & Ana P Teixeira. (2014) Towards real-time monitoring of therapeutic protein quality in mammalian cell processes. Current Opinion in Biotechnology 30, pages 161-167.
Crossref
Crossref
Catherine EM Hogwood, Daniel G Bracewell & C Mark Smales. (2014) Measurement and control of host cell proteins (HCPs) in CHO cell bioprocesses. Current Opinion in Biotechnology 30, pages 153-160.
Crossref
Crossref
Judith Zhu-Shimoni, Christopher Yu, Julie Nishihara, Robert M. Wong, Feny Gunawan, Margaret Lin, Denise Krawitz, Peter Liu, Wendy Sandoval & Martin Vanderlaan. (2014) Host cell protein testing by ELISAs and the use of orthogonal methods. Biotechnology and Bioengineering 111:12, pages 2367-2379.
Crossref
Crossref
Chris Bailey‐Kellogg, Andres H. Gutiérrez, Leonard Moise, Frances Terry, William D. Martin & Anne S. De Groot. (2014) CHOPPI: A web tool for the analysis of immunogenicity risk from host cell proteins in CHO‐based protein production. Biotechnology and Bioengineering 111:11, pages 2170-2182.
Crossref
Crossref
Veronika Reisinger, Hansjoerg Toll, Robert Ernst Mayer, Jan Visser & Florian Wolschin. (2014) A mass spectrometry-based approach to host cell protein identification and its application in a comparability exercise. Analytical Biochemistry 463, pages 1-6.
Crossref
Crossref
Anurag S. Rathore & Rahul Bhambure. (2014) Establishing analytical comparability for “biosimilars”: filgrastim as a case study. Analytical and Bioanalytical Chemistry 406:26, pages 6569-6576.
Crossref
Crossref
Nabila Aboulaich, Wai Keen Chung, Jenny Heidbrink Thompson, Christopher Larkin, David Robbins & Min Zhu. (2014) A novel approach to monitor clearance of host cell proteins associated with monoclonal antibodies. Biotechnology Progress 30:5, pages 1114-1124.
Crossref
Crossref
Amy Farrell, Niaobh McLoughlin, John J. Milne, Ian W. Marison & Jonathan Bones. (2014) Application of Multi-Omics Techniques for Bioprocess Design and Optimization in Chinese Hamster Ovary Cells. Journal of Proteome Research 13:7, pages 3144-3159.
Crossref
Crossref
Chris A Singleton. (2014) MS in the analysis of biosimilars. Bioanalysis 6:12, pages 1627-1637.
Crossref
Crossref
Ying-Yong Zhao & Rui-Chao Lin. (2014) UPLC–MSE application in disease biomarker discovery: The discoveries in proteomics to metabolomics. Chemico-Biological Interactions 215, pages 7-16.
Crossref
Crossref
Nicholas E. Levy, Kristin N. Valente, Leila H. Choe, Kelvin H. Lee & Abraham M. Lenhoff. (2014) Identification and characterization of host cell protein product-associated impurities in monoclonal antibody bioprocessing. Biotechnology and Bioengineering 111:5, pages 904-912.
Crossref
Crossref
Jenny Heidbrink Thompson, Wai Keen Chung, Min Zhu, Liu Tie, Yali Lu, Nabila Aboulaich, Robert Strouse & Wenjun David Mo. (2014) Improved detection of host cell proteins (HCPs) in a mammalian cell-derived antibody drug using liquid chromatography/mass spectrometry in conjunction with an HCP-enrichment strategy. Rapid Communications in Mass Spectrometry 28:8, pages 855-860.
Crossref
Crossref
Maria Juliana Calderan-Rodrigues, Elisabeth Jamet, Maria Beatriz Calderan Rodrigues Bonassi, Simone Guidetti-Gonzalez, Amanda Carmanhanis Begossi, Laís Vaz Setem, Livia Maria Franceschini, Juliana Guimarães Fonseca & Carlos Alberto Labate. (2014) Cell wall proteomics of sugarcane cell suspension cultures. PROTEOMICS 14:6, pages 738-749.
Crossref
Crossref
Birgit Schilling, Brendan X. MacLean, Alexandria D'Souza, Matthew J. Rardin, Nicholas J. Shulman, Michael J. MacCoss & Bradford W. Gibson. 2014. Quantitative Proteomics. Quantitative Proteomics
154
174
.
Lekha SlenoDaryl GS SmithTerry D Cyr. 2014. Applications of High-Resolution Mass Spectrometry in Drug Discovery and Development. Applications of High-Resolution Mass Spectrometry in Drug Discovery and Development
92
105
.
Catalin E. Doneanu & Weibin Chen. 2014. Protein Downstream Processing. Protein Downstream Processing
341
350
.
G. Joucla, C. Le Sénéchal, M. Bégorre, B. Garbay, X. Santarelli & C. Cabanne. (2013) Cation exchange versus multimodal cation exchange resins for antibody capture from CHO supernatants: Identification of contaminating Host Cell Proteins by mass spectrometry. Journal of Chromatography B 942-943, pages 126-133.
Crossref
Crossref
Kate E. Royle, Ioscani Jimenez del Val & Cleo Kontoravdi. (2013) Integration of models and experimentation to optimise the production of potential biotherapeutics. Drug Discovery Today 18:23-24, pages 1250-1255.
Crossref
Crossref
Daniel A. Ribeiro, Douglas F. Passos, Helen C. Ferraz & Leda R. Castilho. (2013) Anion-exchange purification of recombinant factor IX from cell culture supernatant using different chromatography supports. Journal of Chromatography B 938, pages 111-118.
Crossref
Crossref
Cleo Kontoravdi, Nouri J Samsatli & Nilay Shah. (2013) Development and design of bio-pharmaceutical processes. Current Opinion in Chemical Engineering 2:4, pages 435-441.
Crossref
Crossref
Verena Richter, Marcel Kwiatkowski, Maryam Omidi, Azam Omidi, Wesley D Robertson & Hartmut Schlüter. (2013) Mass spectrometric analysis of protein species of biologics. Pharmaceutical Bioprocessing 1:4, pages 381-404.
Crossref
Crossref
Rahul Bhambure, Rohit Sharma, Darpan Gupta & Anurag S. Rathore. (2013) A novel aqueous two phase assisted platform for efficient removal of process related impurities associated with E. coli based biotherapeutic protein products. Journal of Chromatography A 1307, pages 49-57.
Crossref
Crossref
Matthew R. Schenauer, Gregory C. Flynn & Andrew M. Goetze. (2013) Profiling the effects of process changes on residual host cell proteins in biotherapeutics by mass spectrometry. Biotechnology Progress 29:4, pages 951-957.
Crossref
Crossref
Anne Luise Tscheliessnig, Julita Konrath, Ron Bates & Alois Jungbauer. (2013) Host cell protein analysis in therapeutic protein bioprocessing – methods and applications. Biotechnology Journal 8:6, pages 655-670.
Crossref
Crossref
Jingjie Mo, Adrienne A. Tymiak & Guodong Chen. (2013) Characterization of disulfide linkages in recombinant human granulocyte-colony stimulating factor. Rapid Communications in Mass Spectrometry 27:9, pages 940-946.
Crossref
Crossref
Alain Beck, Elsa Wagner-Rousset, Daniel Ayoub, Alain Van Dorsselaer & Sarah Sanglier-Cianférani. (2012) Characterization of Therapeutic Antibodies and Related Products. Analytical Chemistry 85:2, pages 715-736.
Crossref
Crossref
Jingjie Mo, Adrienne A. Tymiak & Guodong Chen. (2012) Structural mass spectrometry in biologics discovery: advances and future trends. Drug Discovery Today 17:23-24, pages 1323-1330.
Crossref
Crossref
Diego F. Cortes, Miranda K. Landis & Andrew K. Ottens. (2012) High‐capacity peptide‐centric platform to decode the proteomic response to brain injury. ELECTROPHORESIS 33:24, pages 3712-3719.
Crossref
Crossref
Matthew R. Schenauer, Gregory C. Flynn & Andrew M. Goetze. (2012) Identification and quantification of host cell protein impurities in biotherapeutics using mass spectrometry. Analytical Biochemistry 428:2, pages 150-157.
Crossref
Crossref
P. A. Marichal-Gallardo & M. M. Álvarez. (2012) State-of-the-art in downstream processing of monoclonal antibodies: Process trends in design and validation. Biotechnology Progress 28:4, pages 899-916.
Crossref
Crossref