Method for producing a freeze-dried composition containing polyclonal IgM and the resulting composition

Abstract

A lyophilized composition comprising polyclonal immunoglobulin M (IgM), comprising the following steps: a) providing an initial aqueous solution containing IgM at a concentration of about 10 mg / mL to about 50 mg / mL, wherein polyclonal IgM accounts for at least about 90% by weight of the total protein content of the composition; b) adding an amino acid or mixture selected from the group consisting of proline, glycine, alanine, valine, and hydroxyproline at a final concentration of about 0.15 M to about 0.45 M, adding polysorbate 80 (PS80) at a concentration of about 50 to about 200 ppm, and adding succinic acid at a concentration of about 1 mM to about 20 mM; c) lyophilizing the IgM composition obtained in step b); the lyophilized composition having a pentameric IgM content of more than about 90% of the total IgM content and an IgM aggregate content of less than about 1.5%.

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