Fig. 3.

Potency ex vivo cell-based assay.

A. Relative potency of Copaxone and Synthon EU FOGA - actual data.

B. Distribution of average relative potency (%) simulated data for Copaxone vs Synthon EU FOGA product - actual data.

Avg = average; LSL = lower specification limit; USL = upper specification limit.

Grey columns represent the distribution of averages of relative potency of 2500 simulated Copaxone mean values, drawn out of the total observed data from 231 lots tested. The red line represents the observed average relative potency of the 6 available Synthon EU FOGA lots.

Note: Specification limits relate to the individual values not averages since the variation of mean values - standard error (SE) is smaller than the variation of individual readings - standard deviation (SD). Therefore, specification limits on chart are given for display purposes only.

C. Relative potency of cytotoxicity induction Copaxone and Synthon EU FOGA product - actual data.