Funder
KAKENHI
Agencia Nacional de Promoción de la Investigación, el Desarrollo Tecnológico y la Innovación
Nakatomi Foundation
Publisher
Springer Science and Business Media LLC
Subject
Pharmacology (medical),Organic Chemistry,Pharmaceutical Science,Pharmacology,Molecular Medicine,Biotechnology
Reference38 articles.
1. Walsh G, Jefferis R. Post-translational modifications in the context of therapeutic proteins. Nat Biotechnol. 2006;24:1241–52. https://doi.org/10.1038/nbt1252.
2. Jenkins N, Murphy L, Tyther R. Post-translational modifications of recombinant proteins: significance for biopharmaceuticals. Mol Biotechnol. 2008;39:113–8. https://doi.org/10.1007/s12033-008-9049-4.
3. Liu H, Gaza-Bulseco G, Faldu D, Chumsae C, Sun J. Heterogeneity of monoclonal antibodies. J Pharm Sci. 2008;97:2426–47. https://doi.org/10.1002/jps.21180.
4. Schadt S, Hauri S, Lopes F, Edelmann MR, Staack RF, Villaseñor R, et al. Are biotransformation studies of therapeutic proteins needed? Scientific considerations and technical challenges. Drug Metab Dispos. 2019;47:1443–56. https://doi.org/10.1124/dmd.119.088997.
5. ICH. S6 (R1) Preclinical safety evaluation of biotechnology-derived pharmaceuticals. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/s6r1-preclinical-safety-evaluation-biotechnology-derived-pharmaceuticals Accessed Jun 22, 2022
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