5,465
Views
33
CrossRef citations to date
0
Altmetric
Report

Biosimilarity under stress: A forced degradation study of Remicade® and Remsima™

, , , , , , , ORCID Icon, , , , & show all
Pages 1197-1209 | Received 01 Feb 2017, Accepted 23 Jun 2017, Published online: 17 Aug 2017

Keep up to date with the latest research on this topic with citation updates for this article.

Read on this site (2)

Michel Degueldre, Annemie Wielant, Eglantine Girot, Will Burkitt, John O’Hara, Gaël Debauve, Annick Gervais & Carl Jone. (2019) Native peptide mapping – A simple method to routinely monitor higher order structure changes and relation to functional activity. mAbs 11:8, pages 1391-1401.
Read now
Christine Nowak, Jason K. Cheung, Shara M. Dellatore, Amit Katiyar, Ram Bhat, Joanne Sun, Gomathinayagam Ponniah, Alyssa Neill, Bruce Mason, Alain Beck & Hongcheng Liu. (2017) Forced degradation of recombinant monoclonal antibodies: A practical guide. mAbs 9:8, pages 1217-1230.
Read now

Articles from other publishers (31)

Patanachai K. Limpikirati, Sorrayut Mongkoltipparat, Thinnaphat Denchaipradit, Nathathai Siwasophonpong, Wudthipong Pornnopparat, Parawan Ramanandana, Phumrapee Pianpakt, Songsak Tongchusak, Maoxin Tim Tian & Trairak Pisitkun. (2023) Basic Regulatory Science Behind Drug Substance and Drug Product Specifications of Monoclonal Antibodies and Other Protein Therapeutics. Journal of Pharmaceutical Analysis.
Crossref
Yan Felix Karl Dyck, Daniel Rehm, Karsten Winkler, Volker Sandig, Wolfgang Jabs & Maria Kristina Parr. (2023) Comparison of middle- and bottom-up mass spectrometry in forced degradation studies of bevacizumab and infliximab. Journal of Pharmaceutical and Biomedical Analysis 235, pages 115596.
Crossref
Tessa Reinert, Rabah Gahoual, Nathalie Mignet, Alexandre Kulus, Matthieu Allez, Pascal Houzé & Yannis-Nicolas François. (2023) Simultaneous quantification and structural characterization of monoclonal antibodies after administration using capillary zone electrophoresis-tandem mass spectrometry. Journal of Pharmaceutical and Biomedical Analysis 233, pages 115446.
Crossref
Gang Wu, Chuanfei Yu, Qinghe Tong, Wenbo Wang, Xi Huang, Hao Li & Lan Wang. (2023) Interlaboratory Co-validation of a UPLC-ToF MS MAM Method for Truncations of a Fc Fusion Protein. Current Pharmaceutical Biotechnology 24:10, pages 1315-1325.
Crossref
Tessa Reinert, Pascal Houzé, Nathalie Mignet, Yannis-Nicolas Francois & Rabah Gahoual. (2023) Post-translational modifications comparative identification and kinetic study of infliximab innovator and biosimilars in serum using capillary electrophoresis-tandem mass spectrometry. Journal of Pharmaceutical and Biomedical Analysis, pages 115541.
Crossref
Pauline Legrand, Sophie Dufaÿ, Nathalie Mignet, Pascal Houzé & Rabah Gahoual. (2022) Modeling study of long-term stability of the monoclonal antibody infliximab and biosimilars using liquid-chromatography–tandem mass spectrometry and size-exclusion chromatography–multi-angle light scattering. Analytical and Bioanalytical Chemistry 415:1, pages 179-192.
Crossref
Daniel D. Vallejo, Chae Kyung Jeon, Kristine F. Parson, Hayley R. Herderschee, Joseph D. Eschweiler, Dana I. Filoti & Brandon T. Ruotolo. (2022) Ion Mobility–Mass Spectrometry Reveals the Structures and Stabilities of Biotherapeutic Antibody Aggregates. Analytical Chemistry 94:18, pages 6745-6753.
Crossref
Daniel D. Vallejo, Carolina Rojas Ramírez, Kristine F. Parson, Yilin Han, Varun V. Gadkari & Brandon T. Ruotolo. (2022) Mass Spectrometry Methods for Measuring Protein Stability. Chemical Reviews 122:8, pages 7690-7719.
Crossref
Daniel D. Vallejo, Jukyung Kang, Jill Coghlan, Carolina Rojas Ramírez, Daniel A. Polasky, Ruwan T. Kurulugama, John C. Fjeldsted, Anna A. Schwendeman & Brandon T. Ruotolo. (2021) Collision-Induced Unfolding Reveals Stability Differences in Infliximab Therapeutics under Native and Heat Stress Conditions. Analytical Chemistry 93:48, pages 16166-16174.
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
Sara M. Shatat, Medhat A. Al-Ghobashy, Faten A. Fathalla, Samah S. Abbas & Basma M. Eltanany. (2021) Coupling of Trastuzumab chromatographic profiling with machine learning tools: A complementary approach for biosimilarity and stability assessment. Journal of Chromatography B 1184, pages 122976.
Crossref
James R. Arndt, Kelly L. Wormwood Moser, Gregory Van Aken, Rory M. Doyle, Tatjana Talamantes, Daniel DeBord, Laura Maxon, George Stafford, John Fjeldsted, Bryan Miller & Melissa Sherman. (2021) High-Resolution Ion-Mobility-Enabled Peptide Mapping for High-Throughput Critical Quality Attribute Monitoring. Journal of the American Society for Mass Spectrometry 32:8, pages 2019-2032.
Crossref
John O. Hui, Tawnya Flick, Joseph A. Loo & Iain D. G. Campuzano. (2021) Unequivocal Identification of Aspartic Acid and iso Aspartic Acid by MALDI-TOF/TOF: From Peptide Standards to a Therapeutic Antibody . Journal of the American Society for Mass Spectrometry 32:8, pages 1901-1909.
Crossref
Rohit Bansal, Saurabh Kumar Jha & Niraj Kumar Jha. (2021) Size-based Degradation of Therapeutic Proteins - Mechanisms, Modelling and Control. Biomolecular Concepts 12:1, pages 68-84.
Crossref
Myriam Nabhan, François-Xavier Legrand, Victor Le-Minh, Baptiste Robin, Rami Bechara, Nicolas Huang, Claire Smadja, Marc Pallardy & Isabelle Turbica. (2020) The FcγRIIa–Syk Axis Controls Human Dendritic Cell Activation and T Cell Response Induced by Infliximab Aggregates. The Journal of Immunology 205:9, pages 2351-2361.
Crossref
Ramsey Saleem, Greg Cantin, Mats Wikström, Glen Bolton, Scott Kuhns, Helen J. McBride & Jennifer Liu. (2020) Analytical and Functional Similarity Assessment of ABP 710, a Biosimilar to Infliximab Reference Product. Pharmaceutical Research 37:6.
Crossref
Lucienne Nouchikian, Cristina Lento, Katherine Donovan, Renwick Dobson & Derek J. Wilson. (2020) Comparing the Conformational Stability of Pyruvate Kinase in the Gas Phase and in Solution. Journal of the American Society for Mass Spectrometry 31:3, pages 685-692.
Crossref
Izabela Sokolowska, Jingjie Mo, Fatie Rahimi Pirkolachahi, Carol McVean, Lars A. T. Meijer, Linda Switzar, Crina Balog, Michael J. Lewis & Ping Hu. (2019) Implementation of a High-Resolution Liquid Chromatography–Mass Spectrometry Method in Quality Control Laboratories for Release and Stability Testing of a Commercial Antibody Product. Analytical Chemistry 92:3, pages 2369-2373.
Crossref
Yoann Le Basle, Philip Chennell, Nicolas Tokhadze, Alain Astier & Valérie Sautou. (2020) Physicochemical Stability of Monoclonal Antibodies: A Review. Journal of Pharmaceutical Sciences 109:1, pages 169-190.
Crossref
Jukyung Kang, Sang Yeop Kim, Daniel Vallejo, Tyler S. Hageman, Derek R. White, Alexander Benet, Jill Coghlan, K. Ilker Sen, Michael Ford, Sergei Saveliev, Thomas J. Tolbert, David D. Weis, Steven P. Schwendeman, Brandon T. Ruotolo & Anna Schwendeman. (2020) Multifaceted assessment of rituximab biosimilarity: The impact of glycan microheterogeneity on Fc function. European Journal of Pharmaceutics and Biopharmaceutics 146, pages 111-124.
Crossref
Jukyung Kang, Troy Halseth, Daniel Vallejo, Zeynab Izadi Najafabadi, K. Ilker Sen, Michael Ford, Brandon T. Ruotolo & Anna Schwendeman. (2019) Assessment of biosimilarity under native and heat-stressed conditions: rituximab, bevacizumab, and trastuzumab originators and biosimilars. Analytical and Bioanalytical Chemistry 412:3, pages 763-775.
Crossref
Yan Felix Karl Dyck, Daniel Rehm, Jan Felix Joseph, Karsten Winkler, Volker Sandig, Wolfgang Jabs & Maria Kristina Parr. (2019) Forced Degradation Testing as Complementary Tool for Biosimilarity Assessment. Bioengineering 6:3, pages 62.
Crossref
Daniel D. Vallejo, Daniel A. Polasky, Ruwan T. Kurulugama, Joseph D. Eschweiler, John C. Fjeldsted & Brandon T. Ruotolo. (2019) A Modified Drift Tube Ion Mobility-Mass Spectrometer for Charge-Multiplexed Collision-Induced Unfolding. Analytical Chemistry 91:13, pages 8137-8146.
Crossref
Lamiaa A. Hassan, Sara M. Shatat, Basma M. Eltanany, Medhat A. Al-Ghobashy & Samah S. Abbas. (2019) Stability and biosimilarity assessment of infliximab using an orthogonal testing protocol and statistically-guided interpretation of peptide mapping. Analytical Methods 11:25, pages 3198-3211.
Crossref
Maja Vimpolsek, Marie Gottar-Guillier & Emmanuel Rossy. (2019) Assessing the Extended In-Use Stability of the Infliximab Biosimilar PF-06438179/GP1111 Following Preparation for Intravenous Infusion. Drugs in R&D 19:2, pages 127-140.
Crossref
Jesús Hermosilla, Ricardo Sánchez-Martín, Raquel Pérez-Robles, Antonio Salmerón-García, Salvador Casares, Jose Cabeza, Luis Cuadros-Rodríguez & Natalia Navas. (2019) Comparative Stability Studies of Different Infliximab and Biosimilar CT-P13 Clinical Solutions by Combined Use of Physicochemical Analytical Techniques and Enzyme-Linked Immunosorbent Assay (ELISA). BioDrugs 33:2, pages 193-205.
Crossref
Beate Beyer, Nicole Walch, Alois Jungbauer & Nico Lingg. (2018) How Similar Is Biosimilar? A Comparison of Infliximab Therapeutics in Regard to Charge Variant Profile and Antigen Binding Affinity. Biotechnology Journal 14:4, pages 1800340.
Crossref
Manca Ogrič, Polona Žigon, David Drobne, Borut Štabuc, Snezna Sodin-Semrl, Saša Čučnik & Sonja Praprotnik. (2018) Routinely utilized in-house assays for infliximab, adalimumab and their anti-drug antibody levels. Immunologic Research 66:6, pages 726-736.
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
Ingrid Schmid, Lea Bonnington, Monika Gerl, Katrin Bomans, Anna Louisa Thaller, Katharina Wagner, Tilman Schlothauer, Roberto Falkenstein, Boris Zimmermann, Jürgen Kopitz, Max Hasmann, Frieder Bauss, Markus Haberger, Dietmar Reusch & Patrick Bulau. (2018) Assessment of susceptible chemical modification sites of trastuzumab and endogenous human immunoglobulins at physiological conditions. Communications Biology 1:1.
Crossref
Paul Chamberlain & Pekka Kurki. 2018. Biosimilars. Biosimilars 489 542 .

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.