Enabling adoption of 2D-NMR for the higher order structure assessment of monoclonal antibody therapeutics

Author:

Brinson Robert G.1,Marino John P.1,Delaglio Frank1,Arbogast Luke W.1ORCID,Evans Ryan M.2,Kearsley Anthony2,Gingras Geneviève3,Ghasriani Houman3ORCID,Aubin Yves3ORCID,Pierens Gregory K.4,Jia Xinying4ORCID,Mobli Mehdi4ORCID,Grant Hamish G.5,Keizer David W.5,Schweimer Kristian6,Ståhle Jonas7ORCID,Widmalm Göran7,Zartler Edward R.8,Lawrence Chad W.9,Reardon Patrick N.9ORCID,Cort John R.9ORCID,Xu Ping10,Ni Feng10,Yanaka Saeko11,Kato Koichi11,Parnham Stuart R.12ORCID,Tsao Desiree13,Blomgren Andreas14ORCID,Rundlöf Torgny14ORCID,Trieloff Nils15ORCID,Schmieder Peter15,Ross Alfred16,Skidmore Ken17,Chen Kang18ORCID,Keire David18ORCID,Freedberg Darón I.19ORCID,Suter-Stahel Thea20,Wider Gerhard20,Ilc Gregor2122,Plavec Janez2122ORCID,Bradley Scott A.23,Baldisseri Donna M.24,Sforça Mauricio Luis25,Zeri Ana Carolina de Mattos26,Wei Julie Yu27,Szabo Christina M.28ORCID,Amezcua Carlos A.28ORCID,Jordan John B.29,Wikström Mats30

Affiliation:

1. Institute of Bioscience and Biotechnology Research, National Institute of Standards and Technology and the University of Maryland, Rockville, MD, USA

2. Applied and Computational Mathematics Division, National Institute of Standards and Technology, Gaithersburg, MD, USA

3. Centre for Biologics Evaluation, Biologics and Genetic Therapies Directorate, Health Canada, Ottawa, ON, Canada

4. The Centre for Advanced Imaging, The University of Queensland, St Lucia, QLD, Australia

5. Bio21 Molecular Science & Biotechnology Institute, The University of Melbourne, Victoria, Australia

6. Lehrstuhl Biopolymere, Universitaet Bayreuth, Bayreuth, Germany

7. Department of Organic Chemistry, Arrhenius Laboratory, Stockholm University, Stockholm, Sweden

8. Analytical R&D, Pfizer Essential Health, Lake Forest, IL, USA

9. Pacific Northwest National Laboratory, Earth and Biological Sciences Directorate, Richland, DC, USA

10. Department of Downstream Processing and Analytics, Human Health Therapeutics Research Centre, National Research Council of Canada, Montreal, Quebec, Canada

11. Institute for Molecular Science and Exploratory Research Center on Life and Living Systems, National Institutes of Natural Sciences, Myodaiji, Okazaki, Japan

12. Department of Biochemistry and Molecular Biology, Medical University of South Carolina, Charleston, SC, USA

13. Analytical Development, Momenta Pharmaceuticals, Cambridge, MA, USA

14. Laboratory Unit, Swedish Medical Products Agency, Laboratory, Uppsala, Sweden

15. NMR-supported Structural Biology, Leibniz-Forschungsinstitut für Molekulare Pharmakologie (FMP), Berlin, Germany

16. Roche Pharmaceutical Research & Early Development, Pre-Clinical CMC, Roche Innovation Center Basel, Basel, Switzerland

17. Analytical Operations, Genentech, South San Francisco, CA, USA

18. Center for Drug Evaluation and Research, Food and Drug Administration, Maryland, USA

19. Center for Biologics Evaluation and Research, Food and Drug Administration, Maryland, USA

20. Department of Biology, Institute of Molecular Biology and Biophysics, ETH Zurich, Zurich, Switzerland

21. NMR Centre, EN-FIST Centre of Excellence, Ljubljana, Slovenia

22. NMR Centre, National Institute of Chemistry, Ljubljana, Slovenia

23. Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, USA

24. MRS – Application Science, Bruker BioSpin Corporation, Billerica, MA, USA

25. Brazilian Biosciences National Laboratory (LNBio), Brazilian Center for Research in Energy and Materials (CNPEM), Campinas, Brazil

26. Brazilian Synchrotron Light Laboratory (LNLS), Brazilian Center for Research in Energy and Materials (CNPEM), Campinas, Brazil, CEP

27. Protein Product Development, Biogen Inc., Cambridge, MA, USA

28. Baxter Pharmaceuticals R&D, Baxter Healthcare, Round Lake, IL, USA

29. Global Regulatory and R&D Policy, Amgen Inc., Thousand Oaks, CA, USA

30. Higher Order Structure, Attribute Sciences, Amgen Inc., Thousand Oaks, CA, USA

Funder

Alice Wallenberg Foundation

Publisher

Informa UK Limited

Subject

Immunology,Immunology and Allergy

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