Abstract

OCA-GARCIA, Daidée Montes de et al. Establishment of the purification scheme for SOBERANA^®02, SOBERANA^®Plus and SOBERANA 01 antigens. Vaccimonitor [online]. 2024, vol.33  Epub Dec 01, 2024. ISSN 1025-0298.

The urgent need to develop and produce safe and effective vaccines to guarantee the reduction of the spread of the type 2 coronavirus that causes severe acute respiratory syndrome, led the Center for Molecular Immunology and the Finlay Vaccine Institute to develop two vaccines and one candidate vaccine to combat the 2019 coronavirus pandemic. As part of the establishment of the production process, experiments were carried out on the possible steps of the purification process of the receptor binding domain molecule (aa 319-541) with a view to its subsequent technological transfer on an industrial scale. This molecule is fused with a hexahistidine tag at its C-terminal end and has nine cysteine residues in its sequence that form four intramolecular disulfide bonds; leaving a free cysteine that allows two molecules to be obtained: dimeric and monomeric, which constitute the antigens of the SOBERANA®02 and SOBERANA®Plus vaccines and the SOBERANA 01 vaccine candidate. The best adsorption conditions of the chromatographic matrices of affinity for metal chelates, cationic exchange and molecular exclusion were determined. The performance of the process was evaluated on a pilot scale and the molecule was characterized according to its physical-chemical and biological properties. The results obtained showed a 60.02 ± 5.15% total recovery of the protein of interest with more than 98% purity in both molecules, an efficient removal of contaminants and an antigenicity greater than 90% referred to the control monomer of the domain receptor binding with 99% purity; which demonstrates that the established process is efficient in obtaining a product with the required quality.

Keywords : COVID-19; vaccines; adsorption.

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