PROTEIN FORMULATIONS AND METHODS OF MAKING SAME

摘要

The invention provides an aqueous formulation comprising water and a protein, and methods of making the same. The aqueous formulation of the invention may be a high protein formulation and/or may have low levels of conductity resulting from the low levels of ionic excipients. Also included in the invention are formulations comprising water and proteins having low osmolality.

主权项

1. An aqueous formulation comprising a protein and water, wherein the formulation has a characteristic selected from the group consisting of:
(a) a conductivity of less than about 2.5 mS/cm, wherein the protein has a molecular weight (Mw) greater than about 47 kDa; (b) an osmolality of no more than about 30 mOsmol/kg; (c) a hydrodynamic diameter (Dh) which is at least about 50% less than the Dh of the protein in a buffered solution at a given concentration; and (d) a hydrodynamic diameter (Dh) of less than about 4 nm.