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Pharmaceutical Development and Technology Volume 26, 2021 - Issue 1
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Research Articles

Developability assessment for monoclonal antibody drug candidates: a case study

Vivek Kumar Garripellia Pharmaceutical Development, Oncology Early Development CMC Biologics, AbbVie, Redwood City, CA, USACorrespondence[email protected]
,
Zhen Wub ADC Therapeutics, San Mateo, CA, USA
&
Supriya Guptaa Pharmaceutical Development, Oncology Early Development CMC Biologics, AbbVie, Redwood City, CA, USA
Pages 11-20 | Received 02 Jan 2020, Accepted 24 Sep 2020, Published online: 14 Oct 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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Articles from other publishers (9)

Joschka Bauer, Nandhini Rajagopal, Priyanka Gupta, Pankaj Gupta, Andrew E. Nixon & Sandeep Kumar. (2023) How can we discover developable antibody-based biotherapeutics?. Frontiers in Molecular Biosciences 10.
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Sergio A. Rodriguez‐Aponte, Christopher A. Naranjo, Ryan S. Johnston, Neil C. Dalvie, Laura E. Crowell, Sakshi Bajoria, Ozan S. Kumru, Sangeeta B. Joshi, David B. Volkin & J. Christopher Love. (2023) Minimal purification method enables developability assessment of recombinant proteins. Biotechnology and Bioengineering.
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Giulia Lambiase, Kerensa Klottrup-Rees, Clare Lovelady, Salma Ali, Samuel Shepherd, Maurizio Muroni, Vivian Lindo, David C. James & Mark J. Dickman. (2023) An automated, low volume, and high-throughput analytical platform for aggregate quantitation from cell culture media. Journal of Chromatography A 1691, pages 463809.
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Hannes Ausserwöger, Matthias M. Schneider, Therese W. Herling, Paolo Arosio, Gaetano Invernizzi, Tuomas P. J. Knowles & Nikolai Lorenzen. (2022) Non-specificity as the sticky problem in therapeutic antibody development. Nature Reviews Chemistry 6:12, pages 844-861.
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Giulia Lambiase, Sophie E. Inman, Maurizio Muroni, Vivian Lindo, Mark J. Dickman & David C. James. (2022) High-throughput multiplex analysis of mAb aggregates and charge variants by automated two-dimensional size exclusion-cation exchange chromatography coupled to mass spectrometry. Journal of Chromatography A 1670, pages 462944.
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Andreas Evers, Didier Clénet & Stefania Pfeiffer-Marek. (2022) Long-Term Stability Prediction for Developability Assessment of Biopharmaceutics Using Advanced Kinetic Modeling. Pharmaceutics 14:2, pages 375.
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Alessandro Pedrioli & Annette Oxenius. (2021) Single B cell technologies for monoclonal antibody discovery. Trends in Immunology 42:12, pages 1143-1158.
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Hermann Wätzig, Marc Hoffstedt, Finja Krebs, Robert Minkner, Christin Scheller & Holger Zagst. (2021) Protein analysis and stability: Overcoming trial-and-error by grouping according to physicochemical properties. Journal of Chromatography A 1649, pages 462234.
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Giulia Lambiase, Sophie E. Inman, Maurizio Muroni, Vivian Lindo, Mark J. Dickman & David C. James. (2022) High-Throughput Multiplex Analysis of Mab Aggregates and Charge Variants by Automated Two-Dimensional Size Exclusion-Cation Exchange Chromatography Coupled to Mass Spectrometry (2d Sec-Cex-Ms). SSRN Electronic Journal.
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