HUMAN T CELL LINE ASSAY FOR EVALUATING THE IMMUNOLOGIC IDENTITY OF GLATIRAMER ACETATE PREPARATIONS

摘要

The invention relates to the field of medicine. The invention provides methods for generating glatiramer-acetate-specific human T-cell lines, and assays that use these T-cell lines for demonstrating immunological identity between glatiramer acetate preparations. These assays allow sensitive and accurate comparison of glatiramer acetate preparations, and find utility as lot-release assays.