Cummings SR, Martin JS, McClung MR, Siris ES, Eastell R, Reid IR, et al. Denosumab for prevention of fractures in postmenopausal women with osteoporosis. N Engl J Med. 2009;361:756–65.
Article CAS PubMed Google Scholar
Sabatine MS, Giugliano RP, Keech AC, Honarpour N, Wiviott SD, Murphy SA, et al. Evolocumab and clinical outcomes in patients with cardiovascular disease. N Engl J Med. 2017;376:1713–22.
Article CAS PubMed Google Scholar
Corren J, Parnes JR, Wang L, Mo M, Roseti SL, Griffiths JM, et al. Tezepelumab in adults with uncontrolled asthma. N Engl J Med. 2017;377:936–46.
Article CAS PubMed Google Scholar
Lesokhin AM, Tomasson MH, Arnulf B, Bahlis NJ, Miles Prince H, Niesvizky R, et al. Elranatamab in relapsed or refractory multiple myeloma: phase 2 MagnetisMM-3 trial results. Nat Med. 2023;29:2259–67.
Article CAS PubMed PubMed Central Google Scholar
Yu J, Song Y, Tian W. How to select IgG subclasses in developing anti-tumor therapeutic antibodies. J Hematol OncolJ Hematol Oncol. 2020;13:1–10.
Vidarsson G, Dekkers G, Rispens T. IgG subclasses and allotypes: From structure to effector functions. Front Immunol. 2014;5:1–17.
Rudge SR, Nims RW. ICH Q6B specifications: test procedures and acceptance criteria for biotechnological/biological products. ICH Quality Guidelines: An Implementation Guide. 2017 Sep 27:467–86.
Lemery SJ, Ricci MS, Keegan P, McKee AE, Pazdur R. FDA’s approach to regulating biosimilars. Clin Cancer Res. 2017;23:1882–5.
Kirchhoff CF, Wang X-ZM, Conlon HD, Anderson S, Ryan AM, Bose A. Biosimilars: key regulatory considerations and similarity assessment tools. Biotechnol Bioeng. 2017;114:2696–705.
Article CAS PubMed PubMed Central Google Scholar
Yu LX, Amidon G, Khan MA, Hoag SW, Polli J, Raju GK, et al. Understanding pharmaceutical quality by design. AAPS J. 2014;16:771–83.
Article CAS PubMed PubMed Central Google Scholar
Patel HM, Noolvi MN, Sharma P, Jaiswal V, Bansal S, Lohan S, et al. Quantitative structure–activity relationship (QSAR) studies as strategic approach in drug discovery. Med Chem Res. 2014;23:4991–5007.
Holm P, Allesø M, Bryder MC, Holm R. Q8 (R2) Pharmaceutical Development. ICH quality guidelines: an implementation guide. 2017 Sep 27:535–77.
Matikonda SS, McLaughlin R, Shrestha P, Lipshultz C, Schnermann MJ. Structure–activity relationships of antibody-drug conjugates: a systematic review of chemistry on the trastuzumab scaffold. Bioconjug Chem. 2022;33:1241–53.
Article CAS PubMed Google Scholar
Harris RJ, Kabakoff B, Macchi FD, Shen FJ, Kwong M, Andya JD, et al. Identification of multiple sources of charge heterogeneity in a recombinant antibody. J Chromatogr B. 2001;752:233–45.
Vlasak J, Ionescu R. Heterogeneity of monoclonal antibodies revealed by charge-sensitive methods. Curr Pharm Biotechnol. 2008;9:468–81.
Article CAS PubMed Google Scholar
Liu S, Madren S, Feng P, Sosic Z. Characterization of the acidic species of a monoclonal antibody using free flow electrophoresis fractionation and mass spectrometry. J Pharm Biomed Anal. 2020;185: 113217.
Article CAS PubMed Google Scholar
Wang L, Wu H, Cao T, Li H, Shen P, Lu L, et al. Identification of structural origins of complex charge heterogeneity in therapeutic ACE2Fc fusion protein facilitated by free-flow isoelectric focusing. Eur J Pharm Biopharm. 2024;198: 114248.
Article CAS PubMed Google Scholar
McKinnon RA, Cook M, Liauw W, Marabani M, Marschner IC, Packer NH, et al. Biosimilarity and interchangeability: principles and evidence: a systematic review. BioDrugs. 2018;32:27–52.
Article CAS PubMed PubMed Central Google Scholar
Mao Q, Pawliszyn J. Capillary isoelectric focusing with whole column imaging detection for analysis of proteins and peptides. J Biochem Biophys Methods. 1999;39:93–110.
Article CAS PubMed Google Scholar
Fekete S, Beck A, Veuthey J-L, Guillarme D. Ion-exchange chromatography for the characterization of biopharmaceuticals. J Pharm Biomed Anal. 2015;113:43–55.
Article CAS PubMed Google Scholar
Ponniah G, Nowak C, Neill A, Liu H. Characterization of charge variants of a monoclonal antibody using weak anion exchange chromatography at subunit levels. Anal Biochem. 2017;520:49–57.
Article CAS PubMed Google Scholar
Yan Y, Liu AP, Wang S, Daly TJ, Li N. Ultrasensitive characterization of charge heterogeneity of therapeutic monoclonal antibodies using strong cation exchange chromatography coupled to native mass spectrometry. Anal Chem. 2018;90:13013–20.
Article CAS PubMed Google Scholar
Sarin D, Kumar S, Rathore AS. Multiattribute monitoring of charge-based heterogeneity of recombinant monoclonal antibodies using 2D HIC-WCX-MS. Anal Chem. 2022;94:15018–26.
Article CAS PubMed Google Scholar
Liu AP, Yan Y, Wang S, Li N. Coupling anion exchange chromatography with native mass spectrometry for charge heterogeneity characterization of monoclonal antibodies. Anal Chem. 2022;94:6355–62.
Article CAS PubMed PubMed Central Google Scholar
Hosken BD, Li C, Mullappally B, Co C, Zhang B. Isolation and characterization of monoclonal antibody charge variants by free flow isoelectric focusing. Anal Chem. 2016;88:5662–9.
Article CAS PubMed Google Scholar
Hanley DA, Adachi JD, Bell A, Brown V. Denosumab: mechanism of action and clinical outcomes. Int J Clin Pract. 2012;66:1139–46.
Article CAS PubMed Google Scholar
Jadidi-Niaragh F. Potential of CD73 as a target for cancer immunotherapy. Immunotherapy. 2019;11:1353–5.
Article CAS PubMed Google Scholar
Brinkhaus M, Pannecoucke E, van der Kooi EJ, Bentlage AEH, Derksen NIL, Andries J, et al. The Fab region of IgG impairs the internalization pathway of FcRn upon Fc engagement. Nat Commun. 2022;13:6073.
Article CAS PubMed PubMed Central Google Scholar
Abramson J, Adler J, Dunger J, Evans R, Green T, Pritzel A, et al. Accurate structure prediction of biomolecular interactions with AlphaFold 3. Nature. 2024;630:493–500.
Article CAS PubMed PubMed Central Google Scholar
Bhattarai S, Pippel J, Scaletti E, Idris R, Freundlieb M, Rolshoven G, et al. 2-Substituted α, β-Methylene-ADP derivatives: potent competitive ecto-5′-nucleotidase (CD73) inhibitors with variable binding modes. J Med Chem. 2020;63:2941–57.
Article CAS PubMed Google Scholar
Xu X, O’Callaghan JA, Guarnero Z, Qiu H, Li N, Potocky T, et al. Low pKa of Lys promotes glycation at one complementarity-determining region of a bispecific antibody. Biophys J. 2022;121:1081–93.
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