Abstract

SUAREZ BATISTA, Lilia et al. Analytical system of evaluation of the biological activity of anti-A hemo-cim hemoclassifier reagent. Rev Cubana Hematol Inmunol Hemoter [online]. 2000, vol.16, n.2, pp. 132-137. ISSN 1561-2996.

With the objective of carrying out industrial scaling of hemoclassifier products from murin monoclonal antibodies, a number of activities were performed to create the conditions for their manufacture in compliance with good manufacturing practices of the Molecular Immunology Center. The analytical methods were introduced to determine the quality of anti-A Hemo-CIM hemoclassifier in the Quality Assurance Department. Staff responsible for this work was trained in the use of these evaluation methods of the biological action of anti-A monoclonal antibody in supernatant, ascitic fluid and finished product; the documents that are part of the documentation system were designed and prepared, among them standard operating procedures, master production batch records, documents for data-gathering, batch records, quality certificates and biological activity measurement registers to file lab results

Keywords : ANTIBODIES, MONOCLONAL [analysis].

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