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A High Threshold of Biotherapeutic Aggregate Numbers is Needed to Induce an Immunogenic Response In Vitro, In Vivo, and in the Clinic.

Autor: Cohen JR; The Department of Process Development, Amgen Inc, One Amgen Center Dr, Thousand Oaks, CA, 91320, USA. jcohen02@amgen.com., Brych SR; The Department of Process Development, Amgen Inc, One Amgen Center Dr, Thousand Oaks, CA, 91320, USA., Prabhu S; The Department of Process Development, Amgen Inc, One Amgen Center Dr, Thousand Oaks, CA, 91320, USA., Bi V; The Department of Biosimilars, Amgen Inc, Thousand Oaks, CA, 91320, USA., Elbaradei A; The Department of Process Development, Amgen Inc, One Amgen Center Dr, Thousand Oaks, CA, 91320, USA., Tokuda JM; The Department of Process Development, Amgen Inc, One Amgen Center Dr, Thousand Oaks, CA, 91320, USA., Xiang C; The Department of Process Development, Amgen Inc, One Amgen Center Dr, Thousand Oaks, CA, 91320, USA., Hokom M; The Department of Clinical Immunology, Amgen Inc, Thousand Oaks, CA, 91320, USA.; Department of BioAnalytical Sciences, Genentech, Inc, South San Francisco, CA, 94080, USA., Cui X; The Department of Process Development, Amgen Inc, One Amgen Center Dr, Thousand Oaks, CA, 91320, USA., Ly C; The Department of Process Development, Amgen Inc, One Amgen Center Dr, Thousand Oaks, CA, 91320, USA., Amos N; The Department of Process Development, Amgen Inc, One Amgen Center Dr, Thousand Oaks, CA, 91320, USA., Sun J; Translational Safety and Bioanalytical Sciences, Amgen Inc, Thousand Oaks, CA, 91320, USA., Calamba D; Translational Safety and Bioanalytical Sciences, Amgen Inc, Thousand Oaks, CA, 91320, USA., Herskovitz J; The Department of Clinical Immunology, Amgen Inc, Thousand Oaks, CA, 91320, USA.; Department of Pharmacology and Experimental Neuroscience, University of Nebraska Medical Center, Omaha, NE, 68198, USA., Capili A; The Department of Process Development, Amgen Inc, One Amgen Center Dr, Thousand Oaks, CA, 91320, USA., Nourbakhsh K; The Department of Process Development, Amgen Inc, One Amgen Center Dr, Thousand Oaks, CA, 91320, USA., Merlo A; The Department of Process Development, Amgen Inc, One Amgen Center Dr, Thousand Oaks, CA, 91320, USA., Carreon J; The Department of Process Development, Amgen Inc, One Amgen Center Dr, Thousand Oaks, CA, 91320, USA., Wypych J; The Department of Process Development, Amgen Inc, One Amgen Center Dr, Thousand Oaks, CA, 91320, USA., Narhi LO; The Department of Process Development, Amgen Inc, One Amgen Center Dr, Thousand Oaks, CA, 91320, USA., Jawa V; The Department of Clinical Immunology, Amgen Inc, Thousand Oaks, CA, 91320, USA.; Department of Pharmacometrics, Disposition & Bioanalysis, Bristol Myers Squibb, Princeton, NJ, 08543, USA., Joubert MK; The Department of Process Development, Amgen Inc, One Amgen Center Dr, Thousand Oaks, CA, 91320, USA. mjoubert@amgen.com.

Publikováno v: Pharmaceutical research [Pharm Res] 2024 Apr; Vol. 41 (4), pp. 651-672. Date of Electronic Publication: 2024 Mar 22.

Increased aggregation propensity of IgG2 subclass over IgG1: role of conformational changes and covalent character in isolated aggregates.

Autor: Franey H; Process and Product Development, Amgen Inc., Thousand Oaks, CA 91320, USA., Brych SR, Kolvenbach CG, Rajan RS

Publikováno v: Protein science : a publication of the Protein Society [Protein Sci] 2010 Sep; Vol. 19 (9), pp. 1601-15.

Effect of ions on agitation- and temperature-induced aggregation reactions of antibodies.

Autor: Fesinmeyer RM; Department of Process and Product Development, AW2/D-3152, Amgen Court West, Seattle, Washington, 98119, USA., Hogan S, Saluja A, Brych SR, Kras E, Narhi LO, Brems DN, Gokarn YR

Publikováno v: Pharmaceutical research [Pharm Res] 2009 Apr; Vol. 26 (4), pp. 903-13. Date of Electronic Publication: 2008 Dec 23.