Pharm Res (2018) 35: 133 https://doi.org/10.1007/s11095-018-2398-1 RESEARCH PAPER Improving Viscosity and Stability of a Highly Concentrated Monoclonal Antibody Solution with Concentrated Proline 1 1 1 1 1 1 Jessica J. Hung & Barton J. Dear & Aileen K. Dinin & Ameya U. Borwankar & Sumarth K. Mehta & Thomas T. Truskett & Keith P. Johnston Received: 9 January 2018 /Accepted: 28 March 2018 /Published online: 30 April 2018 # Springer Science+Business Media, LLC, part of Springer Nature 2018 ABSTRACT same total co-solute concentration, while maintaining a lower Purpose To explain the effects of the osmolyte proline on the total solution osmolarity. protein-protein interactions (PPI), viscosity and stability of . . . highly concentrated antibody solutions in contrast to other KEYWORDS antibody high-concentration proline neutral osmolytes. stability viscosity Methods The viscosity of ~225 mg/mL mAb solutions was measured with proline, glycine and trehalose as a function of pH and co-solute concentration up to 1.3 M. The stability was ABBREVIATIONS assessed via turbidity as well as size exclusion chromatography η Viscosity after 4 weeks storage at 40°C. The PPI strength was assessed η Inherent viscosity inh qualitatively via the high concentration diffusion rate by dy- CF Centrifugal filtration namic light scattering.
Pharmaceutical Research – Springer Journals
Published: Apr 30, 2018
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