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.

Quantitative measurement of the requirement of diverse protein degradation pathways in MHC class I peptide presentation.

Autor: Mamrosh JL; Division of Biology and Biological Engineering, California Institute of Technology, Pasadena, CA 91125, USA.; Amgen Research, Thousand Oaks, CA 91320, USA., Sherman DJ; Division of Biology and Biological Engineering, California Institute of Technology, Pasadena, CA 91125, USA.; Amgen Research, Thousand Oaks, CA 91320, USA., Cohen JR; Process Development, Amgen Inc., Thousand Oaks, CA 91320, USA., Johnston JA; Amgen Research, Thousand Oaks, CA 91320, USA., Joubert MK; Process Development, Amgen Inc., Thousand Oaks, CA 91320, USA., Li J; Division of Biology and Biological Engineering, California Institute of Technology, Pasadena, CA 91125, USA.; Amgen Research, Thousand Oaks, CA 91320, USA., Lipford JR; Amgen Research, Thousand Oaks, CA 91320, USA., Lomenick B; Proteome Exploration Laboratory, California Institute of Technology, Pasadena, CA 91125, USA., Moradian A; Proteome Exploration Laboratory, California Institute of Technology, Pasadena, CA 91125, USA., Prabhu S; Process Development, Amgen Inc., Thousand Oaks, CA 91320, USA., Sweredoski MJ; Proteome Exploration Laboratory, California Institute of Technology, Pasadena, CA 91125, USA., Vander Lugt B; Amgen Research, South San Francisco, CA 94080, USA., Verma R; Division of Biology and Biological Engineering, California Institute of Technology, Pasadena, CA 91125, USA.; Amgen Research, Thousand Oaks, CA 91320, USA., Deshaies RJ; Division of Biology and Biological Engineering, California Institute of Technology, Pasadena, CA 91125, USA.; Amgen Research, Thousand Oaks, CA 91320, USA.

Publikováno v: Science advances [Sci Adv] 2023 Jun 23; Vol. 9 (25), pp. eade7890. Date of Electronic Publication: 2023 Jun 23.

Observation of Heavy-Chain C-Terminal Amidation in Human Endogenous IgG.

Autor: Shah B; Process Development, Amgen Inc. One Amgen Center Drive, Thousand Oaks, CA 91320, USA., Li M; Quality, Amgen Inc. One Amgen Center Drive, Thousand Oaks, CA 91320, USA., Wypych J; Process Development, Amgen Inc. One Amgen Center Drive, Thousand Oaks, CA 91320, USA., Joubert MK; Process Development, Amgen Inc. One Amgen Center Drive, Thousand Oaks, CA 91320, USA., Zhang Z; Process Development, Amgen Inc. One Amgen Center Drive, Thousand Oaks, CA 91320, USA. Electronic address: zzhang@amgen.com.

Publikováno v: Journal of pharmaceutical sciences [J Pharm Sci] 2022 Sep; Vol. 111 (9), pp. 2445-2450. Date of Electronic Publication: 2022 Jun 16.

Use of In Vitro Human Skin Models to Assess Potential Immune Activation In Response to Biotherapeutic Attributes and Process-related Impurities.

Autor: Tokuda JM; Amgen Inc, Thousand Oaks, California 91320, USA. Electronic address: jtokuda@amgen.com., Xie J; Amgen Inc, Thousand Oaks, California 91320, USA., Jawa V; Bristol-Myers Squibb Pharmaceuticals Ltd, Lawrence Township, New Jersey 08648, USA., Hawkins JM; Amgen Inc, Thousand Oaks, California 91320, USA., Ferbas J; Amgen Inc, Thousand Oaks, California 91320, USA., Joh NH; Amgen Inc, Thousand Oaks, California 91320, USA. Electronic address: nate.joh@amgen.com., Joubert MK; Amgen Inc, Thousand Oaks, California 91320, USA. Electronic address: mjoubert@amgen.com.

Publikováno v: Journal of pharmaceutical sciences [J Pharm Sci] 2022 Apr; Vol. 111 (4), pp. 1012-1023. Date of Electronic Publication: 2022 Feb 06.

A cross-industry forum on benchmarking critical quality attribute identification and linkage to process characterization studies.

Autor: Demmon S; Bioproduct Research and Development, Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, 46285, USA., Bhargava S; Process Sciences, Seattle Genetics, Inc., 21823 30th Drive SE, Bothell, WA, 98021, USA., Ciolek D; Pharmaceutical Technology, Daiichi Sankyo Inc., Basking Ridge, NJ, 07920, USA., Halley J; Biomolecular Characterisation Sciences, BioTech Sciences, UCB Group, 216 Bath Road, Slough, Berkshire, SL1 3WE, UK., Jaya N; Process Sciences, Seattle Genetics, Inc., 21823 30th Drive SE, Bothell, WA, 98021, USA., Joubert MK; Attribute Sciences, Amgen Inc., One Amgen Center Drive, M/S 30-1-B, Thousand Oaks, CA, 91320, USA., Koepf E; Protein Development, Biogen, 5000 Davis Drive, Research Triangle Park, NC, 27709, USA., Smith P; Biopharm Product Development and Supply, GlaxoSmithKline, 709 Swedeland Road, King of Prussia, PA, 19406, USA., Trexler-Schmidt M; Pharma Technical Development, Genentech, A Member of the Roche Group, 1 DNA Way, South San Francisco, CA, 94080, USA., Tsai P; Process Sciences, Seattle Genetics, Inc., 21823 30th Drive SE, Bothell, WA, 98021, USA. Electronic address: Ptsai@seagen.com.

Publikováno v: Biologicals : journal of the International Association of Biological Standardization [Biologicals] 2020 Sep; Vol. 67, pp. 9-20. Date of Electronic Publication: 2020 Jul 11.