Formulation Studies of an Adsorbed Conjugate Vaccine - How a thorough formulation study ensured the development of a stable and effective vaccine. - BioPharm International

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Formulation Studies of an Adsorbed Conjugate Vaccine
How a thorough formulation study ensured the development of a stable and effective vaccine.


BioPharm International Supplements



Table 2. Percent adsorption data (method B) for development lots
The PBS formulation was determined to be unstable and unacceptable. New lots were formulated in saline and used for clinical trials. The same formulation has been used for commercial product.

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


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