Copolymer assay

摘要

The present invention provides methods and compositions for evaluating one or more properties of an amino acid copolymer.

主权项

1. A method for determining if a glatiramer acetate preparation is suitable for pharmaceutical use, the method comprising:
(a) providing a myeloid cell; (b) contacting the myeloid cell with interferon-γ (IFN-γ) and a sample of a glatiramer acetate preparation; (c) measuring the production of at least one interferon-γ-induced protein selected from the group consisting of interferon-γ-inducible protein 10 (IP-10), interferon-inducible T cell α-chemoattractant (I-TAC), and monokine induced by interferon-γ (MIG) produced by the myeloid cell; and (d) comparing the production of at least one IFN-γ-induced protein produced by the myeloid cell to a reference value produced by a standardized batch of glatiramer acetate preparation and IFN-γ for the same at least one IFN-γ-induced protein; wherein if the production of said at least one IFN-γ-induced protein in (c) is 80-125% of the reference value, then the glatiramer acetate preparation is suitable for potential pharmaceutical use.