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Springer Nature3
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Pharmaceutical Research1
The AAPS Journal2
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20262
20211
Seth G. Thacker results 3 · Newest (Page 1/1, per page 25)
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Proceedings of the 2024 FDA-CRCG Workshop: Scientific and Regulatory Considerations for Assessment of Immunogenicity Risk for Generic Peptide and Oligonucleotide Drug ProductsNARA Subscribed
The AAPS Journal · 2026 · Vol. 28 · Issue 2 · Springer
Jennifer K. Lee; Ha-Na Lee; Sudhir Agrawal; Joseph A. Balsamo; Andrew Clerman; Sofie Denies; Anne De Groot; Jeremy Fry; Nicolas Gaudenzio; Andrew J. Graves; Kristina E. Howard; SuJin Hwang; Vibha Jawa; Yafei Jin; Logan Kelly-Baker; Emilee Knowlton; Filip Kolenc; Kirthiram Krishnaveni Sivakumar; Jae H. Lee; Yili Li; Likan Liang; Dahui Liu; Yanyan Liu; Robert Lionberger; Markham C. Luke; Mohanraj Manangeeswaran; Mirian Mendoza; Iilun Murphy; Michael Norcross; James E. Polli; Montserrat Puig; Narasimha Rao SP; Hobart Rogers; Anna Schwendeman; Robert Siegel; Sophie Shubow; Noel Smith; Seth G. Thacker; Sophie Tourdot; Kui Yang; Li Zhang; Deyi Zhang; Cameron J. Smith; Eric S. Pang; Daniela Verthelyi
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Multiplexed Immunophenotyping for Innate Activation Assessment Detects Single-Cell Responses to Immunomodulatory Nucleic Acid Impurities in TherapeuticsNARA Subscribed
The AAPS Journal · 2026 · Vol. 28 · Issue 1 · Springer
Joseph A. Balsamo; Mirian Mendoza; Logan Kelly-Baker; Seth G. Thacker; Daniela Verthelyi
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Effect of Fatty Acid Composition in Polysorbate 80 on the Stability of Therapeutic Protein FormulationsNARA Subscribed
Pharmaceutical Research · 2021 · Vol. 38 · Issue 11 · Springer
Melissa A. Pegues; Karol Szczepanek; Faruk Sheikh; Seth G. Thacker; Baikuntha Aryal; Mohamed K Ghorab; Steven Wolfgang; Raymond P. Donnelly; Daniela Verthelyi; V. Ashutosh Rao
Purpose Polysorbate excipients are commonly used as surfactants to stabilize therapeutic proteins in formulations. Degradation of polysorbates could lead to particle formation and instability of the drug formulation. We investigated how the fatty acid composition of polysorbate 80 impacts the degradation profile, particle formation, and product stability under stress conditions. Methods Two polysorbate 80-containing therapeuti...
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