Table 2. Percent adsorption data (method B) for development lots

For commercial product, a resorcinol method (method B) was used to determine percent adsorption. For the 12 development lots examined, the results ranged from 90% to 102% (Table 2); this range is consistent with the variability of the sialic acid assay. Statistical analyses with 99% (one-sided) confidence limits suggested a specification of greater than or equal to 87%. Although the supernatant contained minimal amounts of GCMP, the recovery varied from 90% to 102% and the percent adsorption also varied from 90% to 102%. The change of percent adsorption specification reflected a change in assay method and not a decrease in percent adsorption.

Commercial lots were filled in a Baxter facility in Vienna, Austria, and three lots were placed on long-term stability study.

Figure 2a. Percent adsorption for GCMP–TT in PBS

Figure 2b. pH of GCMP–TT in PBS

Figure 2c. Potency of GCMP–TT in PBS

Figure 2d. Percent adsorption for GCMP–TT in saline

Figure 2e. pH of GCMP–TT in saline

Figure 2f. Potency of GCMP–TT in saline