Abstract

CADIZ, Armando et al. The influence of pH in the stability during the storage of intravenous immunoglobulins for human use. Vaccimonitor [online]. 2000, vol.9, n.1, pp. 21-25. ISSN 1025-0298.

One of the most important requirements that all methods of protein purification for intravenous use must fulfil is the elimination or dissociation of the immunoglobulin aggregates. The use of gel filtration and espectrophotometric techniques showed that acid pH (4.5), gives greater molecular stability to the IgG, dissociating most of the aggregates during lengthy storage using dextrose (5%) as stabilizer, this fact is influenced by the ionic strength of the medium for each pH. Samples with polymers (1-3%) lose them in 6 months. At the same time the use of pH 4.0 showed advantages as the non formation of polymers during the heat of the immunoglobulins, as compared to more basic pH. After 5 minutes of heating the sample at pH 7.0 the absorbance increased in 60% in comparison with the sample at pH 4.0.

Keywords : Intravenous immunoglobulins; aggregates; polymers; dimers; monomers; storage; heating; stability.

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