FDA Extends Shelf Life of 10% Intravenous Immunoglobulin Product from 24 to 36 Months

Yael Waknine

April 21, 2010

April 21, 2010 — The US Food and Drug Administration (FDA) has approved an extended shelf life for 10% liquid intravenous immunoglobulin injection (Privigen, CSL Behring), making it the first product of its kind that can be stored at room temperature for 36 months.

Stabilization of the immunoglobulin with the amino acid proline efficiently minimizes dimer formation and allows extended room temperature storage, company officials said in a news release. The product requires no reconstitution and may be used immediately.

FDA approval was based on physicochemical, biologic, and immunologic data from a 3-year study showing that the immunoglobulin G fraction maintained high purity (≥98%) when the intravenous immunoglobulin product was stored under controlled conditions at 25°C (77°F). Use of proline at pH 4.8 inhibited dimer formation (≤12%) throughout the study period.

Intravenous immunoglobulin therapy is indicated for the treatment of primary immunodeficiency and chronic immune thrombocytopenic purpura. Room temperature storage of the product previously was limited to 24 months.

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