Experimental Substantiation of Cultural Technologies Introduction into Manufacturing of Anti-Rabies Immunoglobulin

The review provides information on the major outcomes of research and development work, performed within the frames of the Federal Target Program “National system of chemical and biological safety” (2009-2014), aimed at elaboration and introduction of cultural techniques into the manufacturing of anti-rabies immunoglobulin. Described are the key phases in methodology engineering, deployed for the large-scale cultivation of fixed rabies virus, concentration of cultural liquid, quantitation of rabies virus using PCR, and immunization of producers. Obtained pilot batches of the enhanced anti-rabies immunoglobulin, complying with normative requirements to commercial formulations, testify to the effectiveness of the developed biotechnological and methodological procedures, as well as of the designed engineering-manufacturing project documentation.

бешенство, вирус бешенства, антирабический иммуноглобулин, культура клеток, иммунизация, ультрафильтрация, стандартная операционная процедура, производственный регламент, фармакопейная статья, rabies, rabies virus, anti-rabies immunoglobulin, cell culture, immunization, ultra-filtration, standard operational procedure, master formula, pharmacopoeial monograph

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