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Assessing Particle Formation of Biotherapeutics in Biological Fluids

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Assessing Particle Formation of Biotherapeutics in Biological Fluids

Journal of Pharmaceutical Sciences

Fecha de publicación: 6 de enero de 2021

DOI: https://doi.org/10.1016/j.xphs.2020.12.038

Autores: Joachim Schuster, Christine E. Probst, Hanns-Christian Mahler, Susanne Joerg, Joerg Huwyler, Roman Mathaes

Background: The stability of therapeutic proteins can be impacted in vivo after administration, which may affect patient safety or treatment efficacy, or both. Stability testing of therapeutic proteins using models representing physiologic conditions may guide preclinical development strategy; however, to date only a few studies assessing the physical stability are available in the public domain. In this manuscript, the stability of seven fluorescently labeled monoclonal antibodies (mAbs) was evaluated in human serum and phosphate-buffered saline, two models often discussed to be representative of the situation in humans after intravenous administration. Subvisible particles were analyzed using light obscuration, flow imaging, and imaging flow cytometry. All methods showed that serum itself formed particles under in vitro conditions. Imaging flow cytometry demonstrated that mean particle size and counts of mAbs increased substantially in serum over five days; however, particle formation in phosphate-buffered saline was comparably low. Stability differences were observed across the mAbs evaluated, and imaging flow cytometry data indicated that fluorescently labeled mAbs primarily interacted with serum components.

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