Stability Indicating Methods for Aluminum Adsorbed Vaccine Products

Abstract

Studies of model proteins found that electrostatic interactions were the major mechanism for adsorption of lysozyme, human growth hormone, diphtheria toxoid, a monoclonal antibody, and PEGylated growth hormone, but that for one protein, ovalbumin, adsorption involved ligand exchange (6). Finished product tests are in-vivo relative potency, concentration determination of aluminum by atomic absorption spectroscopy, safety, sterility, pH, sodium chloride by ionselective probe, benzethonium chloride by titration, and a limit test for formaldehyde using UV-Vis spectroscopy. [...]desorption recovery may vary and recovery can decrease in aged samples (15, 24). Multiple investigators have noted that desorption is more challenging in aged samples (14, 24). [...]development of desorption procedures for stability indi- eating methods should be performed with aged samples when possible.