Preclinical Test of Immunocompounds
Organization and Performance of Preclinical Trails of Immunobiological Compounds According to GLP Requirements.
Tech Area / Field
8 Project completed
Senior Project Manager
Savinova N V
Institute of Bioorganic Chemistry (Branch), Russia, Moscow reg., Puschino
- State Research Center for Applied Microbiology, Russia, Moscow reg., Obolensk\nInstitute of Immunological Engineering, Russia, Moscow reg., Lyubuchany
- Charles River Laboratories, USA, MA, Wilmington
Project summaryAt the present moment one can clearly see the process of market enrichment with medicinal compounds, including immunobiological ones. In Russia and within the EC there is wide experience in development and implementation into health practice of vaccines, immunomodulators and other immunobiological compounds, which constitute both national and international wealth. However, Russia experiences big problems in moving pharmaceuticals forward to foreign markets, first, due to differences between requirements for prectmical and clinical trials in Russia and other countries, in particular, EC countries, and second, because of the lack of facilities, within the wide scope, to test compounds according to world standards. In this connection the problem of creation of a center preclinical and clinical trials of vaccines and other immunobiological compounds is urgent. Taking into account broad experience of researches of the Russian JSC "Biopreparation", in particular, of specialists of the Institute of Engineering Immunology, in the field of biological protection from dangerous and particularly dangerous infections, as well as certain experience of researches of the subsidiary of the Institute of Bioorganic Chemistry in biotechnological works with laboratory animals and in practical trials of safety of different biologically active substances, and die availability at the IBC subsidiary and Animal Breeding Center of premises constructed and operated under GLP international standards, the creation of the suggested center at the RISC "Biopreparation" is expedient and quite justified, and, what is mostly important, quite realistic.
The project is based on the ideas of unifying methods of preclinical trials of vaccine and other compound safety at the expense of the appropriate modernization of production facilities and improvement of trial technology in compliance with the applicable world requirements and recent achievements of biology in this field in Russia and EC countries.
Project Objective: the creation of a center, within the RJSC "Biopreparation", to conduct preclinical trials of immunobiological compounds (vaccines, immune serum compounds, immunomodulators, etc.) in compliance with the requirements accepted in the EC countries, namely according to GLP standards, as well as the center certification on the basis of preclinical trials of medicinal immunobiological biopreparation supported by the ISTC (in particular, chemical tularemia vaccine).
Main tasks to reach the above objective:
- legalization of the center,
- to put into operation and project regime the premises for SPF animals at the animal breeding center (Stolbovaya);
- to ensure work conditions according to GLP standards in the pision of trials of medicinal immunobiological preparations of the Institute of Engineering Immunology and Biologic Centre of the Subsidiary of the Institute of Bioorganic Chemistry.
- to provide training to employes in working according to GLP standards;
- to carry out preclinical GLP trial of the medicinal immunobtological compound supports by the ISTC (in particular, chemical tularemia vaccine);
- to evaluate the importance of immunological load tests in the preclinical vaccine estimation and to determine whether it is necessary to introduce them into protocols of clinical trials;
- to prepare recommendations on performance of preclinical studies according to GL requirements to be included subsequently into normative documents after approval с control authorities of Russia;
- to prepare a package of standardized procedures of the experimental works (SOPaccording to GLP standards;
- to prepare for and conduct intrarepublican and international certification of the preclinical trial center within the frame of RJSC "Biopreparation";
- to provide conditions to obtain the required number of SPF-animals used for preclinical studies of medicinal immunobiological preparations (МШР); J N
- to arrange for breeding of the required number of SPF-animals required for preclinical trials;
- to monitor, on a permanent basis, the health status of laboratory animals.