Formulation suitable for stabilizing proteins, which is free of mammalian excipients

摘要

A formulation free of protein which stabilizes pharmaceutical active proteins, peptides, or mixtures thereof in large scale production processes comprising a mixture of a hydrophilic polymer and a non-ionic detergent, and a mixture of a polyalcohol and a sugar. In some embodiments the polyalcohol is absent.

主权项

1. A formulation free of proteins comprising,
(a) a hydrophilic polymer; (b) a sugar; (c) a non-ionic detergent; and (d) a polyalcohol,wherein the weight ratio of polyalcohol to sugar is from 2:1 to 5:1 (wt-%), wherein the weight ratio between the hydrophilic polymer and the non-ionic detergent is from 18:1 to 22:1 (wt-%), and wherein the non-ionic detergent is present in said formulation in an amount between 0.2 and 0.01 mg/g.