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mAbs Volume 12, 2020 - Issue 1
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Rational optimization of a monoclonal antibody improves the aggregation propensity and enhances the CMC properties along the entire pharmaceutical process chain

Joschka Bauera Early Stage Pharmaceutical Development, Pharmaceutical Development Biologicals, Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach/Riss, Germany
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Sven Mathiasb Institute of Applied Biotechnology, University of Applied Sciences Biberach, Biberach/Riss, Germany;c Early Stage Bioprocess Development, Bioprocess Development Biologicals, Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach/Riss, Germany
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Sebastian Kubea Early Stage Pharmaceutical Development, Pharmaceutical Development Biologicals, Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach/Riss, Germany
,
Kerstin Otteb Institute of Applied Biotechnology, University of Applied Sciences Biberach, Biberach/Riss, Germany
,
Patrick Garidela Early Stage Pharmaceutical Development, Pharmaceutical Development Biologicals, Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach/Riss, Germany
,
Martin Gamerc Early Stage Bioprocess Development, Bioprocess Development Biologicals, Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach/Riss, Germany
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Michaela Blecha Early Stage Pharmaceutical Development, Pharmaceutical Development Biologicals, Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach/Riss, Germany
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Simon Fischerd Cell Line Development, Bioprocess Development Biologicals, Boehringer Ingelheim Pharma GmbH & Co. KG, Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach/Riss, Germany
&
Anne R Karow-Zwicka Early Stage Pharmaceutical Development, Pharmaceutical Development Biologicals, Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach/Riss, GermanyCorrespondence[email protected]
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Article: 1787121 | Received 20 Dec 2019, Accepted 18 Jun 2020, Published online: 13 Jul 2020

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Carl Mieczkowski, Xuejin Zhang, Dana Lee, Khanh Nguyen, Wei Lv, Yanling Wang, Yue Zhang, Jackie Way & Jean-Michel Gries. (2023) Blueprint for antibody biologics developability. mAbs 15:1.
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Taichi Kuramochi, Siok Wan Gan, Adrian W.S. Ho, Bei Wang, Nagisa Kageji, Takeru Nambu, Sayaka Iida, Momoko Okuda-Miura, Wei Shan Chia, Chiew Ying Yeo, Dan Chen, Wen-Hsin Lee, Eve Zi Xian Ngoh, Siti Nazihah Mohd Salleh, Cheng-I Wang, Tomoyuki Igawa & Hideaki Shimada. (2022) Comprehensive engineering of a therapeutic neutralizing antibody targeting SARS-CoV-2 spike protein to neutralize escape variants. mAbs 14:1.
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Giuseppe Licari, Kyle P. Martin, Maureen Crames, Joseph Mozdzierz, Michael S. Marlow, Anne R. Karow-Zwick, Sandeep Kumar & Joschka Bauer. (2022) Embedding Dynamics in Intrinsic Physicochemical Profiles of Market-Stage Antibody-Based Biotherapeutics. Molecular Pharmaceutics 20:2, pages 1096-1111.
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Domenico Rizzo, Linda Cerofolini, Stefano Giuntini, Luisa Iozzino, Carlo Pergola, Francesca Sacco, Angelo Palmese, Enrico Ravera, Claudio Luchinat, Fabio Baroni & Marco Fragai. (2022) Epitope Mapping and Binding Assessment by Solid-State NMR Provide a Way for the Development of Biologics under the Quality by Design Paradigm. Journal of the American Chemical Society 144:22, pages 10006-10016.
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Dheeraj S. Tomar, Giuseppe Licari, Joschka Bauer, Satish K. Singh, Li Li & Sandeep Kumar. (2022) Stress-dependent Flexibility of a Full-length Human Monoclonal Antibody: Insights from Molecular Dynamics to Support Biopharmaceutical Development. Journal of Pharmaceutical Sciences 111:3, pages 628-637.
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R. Prabakaran, Puneet Rawat, Nobuaki Yasuo, Masakazu Sekijima, Sandeep Kumar & M. Michael Gromiha. (2021) Effect of charged mutation on aggregation of a pentapeptide: Insights from molecular dynamics simulations. Proteins: Structure, Function, and Bioinformatics 90:2, pages 405-417.
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Shawn Shouye Wang, Yifei (Susie) Yan & Kin Ho. (2021) US FDA-approved therapeutic antibodies with high-concentration formulation: summaries and perspectives. Antibody Therapeutics 4:4, pages 262-272.
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Lucky Ahmed, Priyanka Gupta, Kyle P. Martin, Justin M. Scheer, Andrew E. Nixon & Sandeep Kumar. (2021) Intrinsic physicochemical profile of marketed antibody-based biotherapeutics. Proceedings of the National Academy of Sciences 118:37.
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Puneet Rawat, R. Prabakaran, Sandeep Kumar & M. Michael Gromiha. (2021) AbsoluRATE: An in-silico method to predict the aggregation kinetics of native proteins. Biochimica et Biophysica Acta (BBA) - Proteins and Proteomics 1869:9, pages 140682.
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David Saleh, Rudger Hess, Michelle Ahlers‐Hesse, Nicole Beckert, Markus Schönberger, Federico Rischawy, Gang Wang, Joschka Bauer, Michaela Blech, Simon Kluters, Joey Studts & Jürgen Hubbuch. (2021) Modeling the impact of amino acid substitution in a monoclonal antibody on cation exchange chromatography. Biotechnology and Bioengineering 118:8, pages 2923-2933.
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Mohamed A. Alfaleh, Hashem O. Alsaab, Ahmad Bakur Mahmoud, Almohanad A. Alkayyal, Martina L. Jones, Stephen M. Mahler & Anwar M. Hashem. (2020) Phage Display Derived Monoclonal Antibodies: From Bench to Bedside. Frontiers in Immunology 11.
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