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Size Exclusion Chromatography 

[0392] The stability of the Block B formulations was evaluated by measuring the amount of non-degraded afliber› cept present in the formulation at time 0 (t0) and after being subjected to storage conditions. Size Exclusion Chromatog› raphy was conducted on the formulations and the percentage of protein present in the main peak (non-degraded afliber› cept) in each formulation is reported in Table 18-21 below. 

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[0393] The initial monomer contents were 98-99%. After storage for one week at 40° C., monomer contents decreased to about 97%, with small differences being apparent. The losses were entirely due to aggregation and not due to fragmentation, again emphasizing the nature of the primary degradation pathway. 

[0394] After two weeks at 25° C., the monomer contents were mostly near 98%. The two nominal pH 7 formulations 

