2D-MALLS, IMMS, and AFM Assays.
A. 2D-MALLS. Molecular mass elution profiles as a function of hydrophobicity for Copaxone and Synthon EU FOGA lots.
2D-MALLS = 2 dimensional multi angle laser light scattering; EU = European Union; FOGA = follow-on glatiramer acetate Synthon EU FOGA samples are shown in red; 6 lots of Copaxone (overlay) are shown in blue.
B. IMMS. The pixel-by-pixel compositional comparison of Synthon lots to a randomly selected Copaxone lot identified extensive differences (as exemplifed by the red and blue dots in the scattergraph of Clift 1503711E). IMMS = ion mobility mass spectrometry; Red = above range; Blue = below range; White = within range of COPAXONE's microheterogeneity, as tested by 6 randomly selected lots of similar expiration dates.
C. AFM. Comparison of Copaxone and Synthon EU FOGAs are generally similar in morphology. EU = European Union; FOGA = follow-on glatiramer acetate.