METHODS FOR REDUCING LIPASE ACTIVITY

Abstract

Pharmaceutical formulations comprising an antibody that specifically binds to human interleukin-4 receptor alpha (hIL-4Ra) are provided. The formulations may contain, in addition to an anti-IL-4Ra antibody, one or more buffers, at least one amino acid, at least one sugar, and a surfactant comprising a polysorbate, polyethylene glycol or a poloxamer. Methods for producing pharmaceutical formulations with reduced lipase activity are also provided, which may include subjecting a drug substance to anion exchange chromatography in acidic conditions, agitation stress, heat stress, and additional ion exchange or size exclusion chromatography. In one aspect, the pharmaceutical formulations do not have appreciable subvisible particle formation in the presence of lipase, and exhibit a substantial degree of antibody stability during storage and after being subjected to thermal and other physical stresses.

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