Polysorbate 20 degradation in biopharmaceutical formulations: quantification of free fatty acids, characterization of particulates, and insights into the degradation mechanism A Tomlinson, B Demeule, B Lin, S Yadav Molecular pharmaceutics 12 (11), 3805-3815, 2015 | 148 | 2015 |
Exogenous delivery of chaperonin subunit fragment ApiCCT1 modulates mutant Huntingtin cellular phenotypes EM Sontag, LA Joachimiak, Z Tan, A Tomlinson, DE Housman, CG Glabe, ... Proceedings of the National Academy of Sciences 110 (8), 3077-3082, 2013 | 84 | 2013 |
Micellar morphology of polysorbate 20 and 80 and their ester fractions in solution via small-angle neutron scattering J Nayem, Z Zhang, A Tomlinson, IE Zarraga, NJ Wagner, Y Liu Journal of pharmaceutical sciences 109 (4), 1498-1508, 2020 | 53 | 2020 |
Identification and characterization of polysorbate-degrading enzymes in a monoclonal antibody formulation T Graf, A Tomlinson, IH Yuk, R Kufer, B Spensberger, R Falkenstein, ... Journal of Pharmaceutical Sciences 110 (11), 3558-3567, 2021 | 48 | 2021 |
Characterization of polysorbate ester fractions and implications in protein drug product stability A Tomlinson, IE Zarraga, B Demeule Molecular pharmaceutics 17 (7), 2345-2353, 2020 | 44 | 2020 |
Improving prediction of free fatty acid particle formation in biopharmaceutical drug products: incorporating ester distribution during polysorbate 20 degradation N Doshi, J Martin, A Tomlinson Molecular pharmaceutics 17 (11), 4354-4363, 2020 | 41 | 2020 |
Novel markers to track oxidative polysorbate degradation in pharmaceutical formulations S Dahotre, A Tomlinson, B Lin, S Yadav Journal of Pharmaceutical and Biomedical Analysis 157, 201-207, 2018 | 34 | 2018 |
A rapid high-sensitivity reversed–phase ultra high performance liquid chromatography mass spectrometry method for assessing polysorbate 20 degradation in protein therapeutics Y Cheng, M Hu, C Zamiri, T Carcelen, B Demeule, A Tomlinson, J Gu, ... Journal of Pharmaceutical Sciences 108 (9), 2880-2886, 2019 | 25 | 2019 |
Extended characterization and impact of visible fatty acid particles-a case study with a mAb product M Saggu, B Demeule, L Jiang, D Kammerer, PK Nayak, M Tai, N Xiao, ... Journal of pharmaceutical sciences 110 (3), 1093-1102, 2021 | 24 | 2021 |
Evaluating a modified high purity polysorbate 20 designed to reduce the risk of free fatty acid particle formation N Doshi, K Ritchie, T Shobha, J Giddings, K Gregoritza, R Taing, ... Pharmaceutical research 38, 1563-1583, 2021 | 19 | 2021 |
Characterization of recombinantly-expressed hydrolytic enzymes from Chinese hamster ovary cells: identification of host cell proteins that degrade polysorbate D Kovner, IH Yuk, A Shen, H Li, T Graf, S Gupta, W Liu, A Tomlinson Journal of Pharmaceutical Sciences 112 (5), 1351-1363, 2023 | 17 | 2023 |
An information theoretic framework reveals a tunable allosteric network in group II chaperonins T Lopez, K Dalton, A Tomlinson, V Pande, J Frydman Nature structural & molecular biology 24 (9), 726-733, 2017 | 16 | 2017 |
A mechanistic understanding of monoclonal antibody interfacial protection by hydrolytically degraded polysorbate 20 and 80 under IV bag conditions A Kannan, J Giddings, S Mehta, T Lin, A Tomlinson, K Ritchie, I Shieh, ... Pharmaceutical Research 39 (3), 563-575, 2022 | 10 | 2022 |
Modified mammalian cells MW Laird, S Misaghi, A Shen, A Tomlinson, IH Yuk US Patent 12,098,365, 2024 | | 2024 |
Composition and methods for stabilizing liquid protein formulations A Tomlinson, BL Demeule, IAE Zarraga US Patent App. 18/531,442, 2024 | | 2024 |
Polysorbate Mixtures Having Modified Fatty Acid Ester Distribution S Yadav, N Doshi, T Shobha, A Tomlinson, A Srivastava US Patent App. 18/495,374, 2024 | | 2024 |
Composition and methods for stabilizing liquid protein formulations A Tomlinson, BL Demeule, IAE Zarraga US Patent 11,865,177, 2024 | | 2024 |
Polysorbate mixtures having modified fatty acid ester distribution S Yadav, N Doshi, T Shobha, A Tomlinson, A Srivastava US Patent 11,833,206, 2023 | | 2023 |
Technical assessment approach for vendor initiated changes of direct materials E Huang, M Rempt, K Calhoun, T Kaiser, R Quadflieg, P Maillan, ... | | 2018 |