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June 1994

Impurities in Granulocyte Colony-Stimulating Factor?

Author Affiliations

Amgen Center Thousand Oaks, CA 91320-1789 Mitzi Armstrong, RN, MN Thousand Oaks, Calif

Arch Dermatol. 1994;130(6):799. doi:10.1001/archderm.1994.01690060137022

The case presented by Samlaska and Noyes1 in the May 1993 issue of the Archives of a patient who developed pruritus and erythematous edematous plaques at granulocyte colony-stimulating factor (G-CSF) injection sites is very interesting and unique with regard to the authors' conjecture at possible causation. The authors theorized that the skin reaction may have been due to impurities within a specific lot of G-CSF.

Filgrastim (G-CSF) is a sterile, clear, colorless, preservative-free liquid for parenteral administration produced by recombinant DNA technology. Product purity is determined by several assay methods designed to assess levels of potential contaminating DNA, protein, and endotoxins. Additionally, each lot of product is characterized by a number of assays that assess filgrastim integrity, identity, and activity. Assays and tests are performed using the most sophisticated technology available for the characterization of proteins. All methods are validated and approved by the Food and Drug Administration for