Resumo

CADIZ LAHENS, Armando et al. PRODUCTION IN CUBA OF AN ANTI-SARS-COV-2 HYPERIMMUNE INTRAVENOUS IMMUNOGLOBULIN WITH PLASMA FROM CONVALESCENT PATIENTS. Rev. CENIC Cienc. Biol [online]. 2023, vol.54, pp. 222-231.  Epub 04-Dez-2023. ISSN 2221-2450.

Was demonstrated the possibility of obtaining an anti-Covid-19 hyperimmune immunoglobulin preparation for intravenous application route obtained from the plasma of convalescents of this disease. The obtained immunoglobulin has a titer of 458.03 U/mL, showing an activity concentration factor 5.3 times higher compared to the source plasma, which allows the administration of a greater amount of antibodies per volume unit with an expected decrease in adverse reactions associated with direct plasma administration. To obtain it, a technological improvement of the INTACGLOBIN ® production platform was used, an intravenous immunoglobulin with an intact molecule at acidic pH with clinical use since 1988. An authorization was obtained from the Center for the State Control of Medicines, Medical Equipment and Devices (CECMED) to execute a phase-1 clinical trial.

Palavras-chave : SARS-CoV-2, immunoglobulin; hiperimmune; anti-Covid-19.

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