Heterologous Anti-Rabies Immunoglobulin - Results of the First Five Years of Production

Problemy Osobo Opasnykh Infektsii

Никифоров

et al. 2011

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КЛЕТОЧНЫЕ КУЛЬТУРЫ В ПРОИЗВОДСТВЕ ГЕТЕРОЛОГИЧНОГО АНТИРАБИЧЕСКОГО ИММУНОГЛОБУЛИНАФКУЗ «Российский научно-исследовательский противочумный институт «Микроб», Саратов В обзоре обозначены основные современные направления получения антирабического иммуноглобулина с улучшенными свойствами. Проанализированы результаты исследований, связанные с применением вируса бешенства, выращенного на клеточных культурах, в производстве гетерологичного антирабического иммуноглобулина.Ключевые слова: гетерологичный антирабический иммуноглобулин, культура клеток, профилактика бешенства, рабический антиген. This paper reviews basic modern trends in obtainment of anti-rabies immunoglobulin with enhanced properties. One of these trends is associated with the substitution of organ-tissue antigen by cultural antigen at the stage of producer immunization. Analyzed are the results of research connected with the use of the cell-cultures grown Rabies virus in production of heterologous anti-rabies immunoglobulin. The study testifies of applicability of the transferred Vero cell culture as a substrate for rabies antigen preparation. In addition to this, specified are the advantages of the rabies cultural antigen usage over the organ-tissue one at the stage of hyper-immune serum production.

unclassified

Cell Structures in Heterologous Anti-Rabies Immunoglobulin Production

Генералов

Problemy Osobo Opasnykh Infektsii

Никифоров

et al. 2011

Self Cite

<i>In vitro</i> methods for rabies virus detection, and evaluation of their use in the production of rabies immunoglobulin

Гаврилова

Генералов

Biological Products. Prevention, Diagnosis, Treatment

et al. 2021

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Current highly sensitive methods for rabies virus and rabies antibodies detection in biological material can be used not only for diagnosis and experimental research, but also for the production of antirabies medicines used for postexposure prophylaxis. The aim of the study was to analyse existing methods for rabies virus and rabies antibodies detection and to assess the potential for using these methods at the control stages during production of heterologous antirabies immunoglobulin obtained from equine serum. The search for cutting-edge highly sensitive in vitro control methods that could compete with the biological method, which is the main method used in antirabies immunoglobulin control, is an important prerequisite for improvement of the production technology and the quality of antirabies medicines. The study demonstrated that the following test methods can be used in the production of antirabies immunoglobulin: fluorescent antibody technique, enzyme-linked immunosorbent assay, cell culture methods, atomic force microscopy, and flow cytometry. These methods could be used alone or as an alternative to the biological method in white mice. These methods were chosen because of their high sensitivity, specificity, rapid and easy implementation, cost-effectiveness, and automatic recording of test results.

Registration Documentation and Amendments to It as an Element of a Quality Management System in Production of Anti-Rabies Immunoglobulin (Review)

Лобовикова

Shulgina

Razrabotka i registraciâ lekarstvennyh sredstv

et al. 2019

Introduction. Documentation is an integral part of the quality management system, a key element of production and quality control of medicines. A necessary condition for the Rules of good manufacturing practice and guaranteed production of quality products is compliance with the requirements set out in the documents of the registration dossier for the drug. During the life cycle of a drug, post-registration changes in the dossier may be required. Text. This work is an analytical review of changes in the documents of the registration dossier for the drug «Immunoglobulin antirabic from horse blood serum liquid», solution for injections, reflecting the improvement of biotechnology of drug production and methods of its control in the post – registration period. The first post-registration changes in the regulatory documentation were administrative in nature and did not require examination of samples of the drug. The next group of changes in the documents of the registration dossier was due to the expansion of production, reconstruction of technological sites and the introduction of innovative technologies in order to comply with the requirements of GMP, as well as improving the consumer properties of the drug. The last group of changes concerned the revision of methods of quality control of finished products associated with the introduction of modern analytical equipment, expanding the list of standards and bringing into compliance with the requirements of the state Pharmacopoeia XIII edition. Conclusion. The timely introduction of changes into documents of the registration dossier allows you to optimize the procedure for the conduct of internal and external control of rabies immunoglobulin, as well as to avoid violations related to the actualization of the technological documentation. The analysis of changes in the documents of the registration dossier for the drug «Immunoglobulin antirabic from horse blood serum liquid», solution for injections, reflecting the improvement of biotechnology of drug production and methods of its control in the post-registration period. Timely changes in the documents of the registration dossier allow to optimize the procedure of internal and external quality control of anti-rabies immunoglobulin, as well as to avoid violations associated with the updating of technological documentation.