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Horn, Jacqueline; Jena, Sampeeti; Aksan, Alptekin and Friess, Wolfgang (2019): Freeze/thaw of IGG solutions. In: European Journal of Pharmaceutics and Biopharmaceutics, Vol. 134: pp. 185-189

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In this communication, the effect of mannitol and trehalose crystallization on the unfolding of IgG(1), a monoclonal antibody, in the frozen state with repeat freeze/thaw under different pH conditions was explored. Formulations were annealed at -20 degrees C for 20 h five times (interrupted by freeze/thaw). This was done to induce excipient crystallization. Characterization of the frozen-thawed samples was performed by circular dichroism, particle analysis, and size exclusion chromatography. At a pH of 3, formation of insoluble and soluble aggregates was observed however, these could be reduced by the use of a surfactant. Cryoprotectant free formulations showed higher monomer content after freeze/thaw. At pH 5, a single freeze/thaw cycle did not result in a significant increase in particle numbers. At pH range of 4-7 however, aggregate formation in the size range of 1-25 mu m was observed after 5 freeze/thaw cycles.

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