Developability assessment of biologics by integrated biologics profiling

American Pharmaceutical Review

Volumn 17, Issue 5, 2014, Pages

  Lorenz, Thorsten ^a   Fiaux, Jocelyne ^a   Heitmann, Daniel ^a   Gupta, Kapil ^a   Kocher, Hans P ^a   Knopf, Hans Peter ^a   Hartmann, Steffen ^a  

^a Protein Sciences and Design   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANTIBODY; BIOLOGICAL PRODUCT;

ANALYTIC METHOD; ARTICLE; BIOLOGICAL THERAPY; CHO CELL LINE; DRUG DESIGN; DRUG MANUFACTURE; DRUG SCREENING; NONHUMAN;

EID: 84911949410     PISSN: 10998012     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (9)

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3. Yang X, et al. Developability studies before initiation of process development. mAbs. 2013;5(5):787-794.
4. Jostock T, Knopf HP. Mammalian stable expression of bio therapeutics. Methods Mol Biol. 2012;899:227-238.
5. Liu H, et al. Heterogeneity of monoclonal antibodies. J Pharm Sci. 2008 Jul;97(7):2426-47.
6. Jenkins N, et al. Post-translational modifications of recombinant proteins: significance for biopharmaceuticals. Mol Biotechnol. 2008 Jun;39(2):113-118.
7. Yadav S, Shire SJ, Kalonia DS. Viscosity behavior of high-concentration monoclonal antibody solutions: correlation with interaction parameter and electro viscous effects. J Pharm Sci. 2012 Mar;101(3):998-1011.
8. Connolly BD, et al. Weak interactions govern the viscosity of concentrated antibody solutions: high-throughput analysis using the diffusion interaction parameter. Biophys J. 2012;103:69-78.
9. Neergaard MS, et al. Viscosity of high concentration protein formulations of monoclonal antibodies of the IgG1 and IgG4 subclass-prediction of viscosity through protein-protein interaction measurements. Eur J Pharm Sci. 2013 Jun 14;49(3):400-410.