Capabilities and perspectives at the State Research Center for Applied Microbiology for addressing biosafety problems in the system of international collaboration

V.Ya. Volkov

State Research Center of Applied Microbiology, Obolensk, Moscow region, Russia

It is well known, that « infections do not know borders ». It predetermines necessity of the international cooperation for prevention of both natural and terrorist epidemics. Successful international cooperation is possible in the presence of the developed national systems of antiepidemic population protection of the countries. Russian «antiplague system», created almost 100 years ago, is one of the most effective in the world. It fruitfully cooperates with medical services of the neighboring state and WHO. During its existence in the Soviet Union and, accordingly, in Russia there were no any scaled epidemics with catastrophic consequences.

At the same time, scientific progress has led to new hazardous occurrence, connected with the advent of genetically modified organisms and their integration into wildlife. Scaled application of antibacterial preparations in medicine and veterinary also has led to the occurrence of a great number of new forms of microorganisms, resistant to antibiotics etc.

In the 70-th of the last century the community are sensed this dangerous situation, including possible military application. Now it is clear, that the prognosis was inexact and bioterrorism has come first. Anyway, the decision, accepted at the state level, to create a number of new scientific research institutes in order to liquidate country lag in the field of molecular biology and genetics was rather timely. And in 1974 All-Union Institute for Applied Microbiology was established. The main purpose of the Institute was showing up and researching of new potentially dangerous microorganisms, including microorganisms, created by methods of genetic engineering, development of modern means of diagnostics, prophylaxis and treatment of infectious diseases in humans and animals, and also the organization of their production.

The institute is situated not far from Moscow, in Obolensk, Moscow region. Such geographical position has provided interaction of the institute with the Biological Research Centre of the Academy of Sciences in Pushcino, and also the research organizations of the various ministries and departments in Moscow, has facilitated training and taking on the highly skilled staff and its objectivity was speeding up application of the academic science achievements to practice. Building of research-and-production complex and scientific formation was simultaneously conducted. The high priority of this problem, allowed to invite known scientists in the institute and to select the most gifted graduates of leading institutes of the country. The majority of young specialists were aimed at studying post-graduate course or working on probation in the best universities and institutes of the country, including antiplague system organizations.

As a result, at the beginning of the 80-th in All-Union Research Institute for Applied Microbiological there was a universal group of scientific and technical specialists, capable to solve scientific and applied objectives in the field of molecular and technical microbiology. As a result, already in 1981-1985 the complex technology was developed [1] and industrial enzyme production of revertase (inverse transcriptase), necessary for maintenance of genetic engineering works in the country was organized. The developers of this technology with factory specialists were awarded by the prestigious State premium.

In 1986 the institute specialists started to work in the new laboratory building (№1), designed and built specially for the safe research of pathogens, including genetically modified ones. Engineering systems of the building provide personnel protection and exclude agent penetration into environment. Biological protection of SRCAM laboratories meets to a maximum level of biosafety for work with highly pathogenic bacteria (BSL3 with elements BSL4). It has provided an opportunity of studying of fundamental bases of nature of the main pathogens, in particular, anthrax [2].

In 1994 the institute became the State Research Center of RF and began to be called SRCAM. Then our contacts with the ISTC were initiated, and financing of the first ecology project was started. Already next year the first international workshop “Development of vaccines against bacterial infections. Pre-clinical and clinical trials” in SRCAM under the aegis of the ISTC was held.

Today the State Research Center of Applied Microbiology is fully involved in activities of the International Science and Technology Center. Most projects focus on diagnostics, prophylaxis and treatment of diseases in humans and animals, such as plague, anthrax, tularemia, tuberculosis, diphtheria, and a number of other infections. Some projects deal with problems of ecology and the development of novel biopreparations for plant protection.

At present, among our partners are the Ministry of Defense, Ministry of Agriculture, Ministry of Energy, Ministry of Health of the United States of America, NASA and a number of other American institutions.

The program of travel support has made it possible for our specialists to visit many foreign research centers and institutions, exchange results, acquire new experience, and to make business contacts. Diversified ISTC- associated activities, including preparation of project proposals, work plants, routine work with specialists from the ISTC, participation in conferences, workshops and training programs has brought a new generation of managers succeeding in the new economic environment and creating research teams, which compete successfully with Western scientists.

SCRAM’s data ware has improved with ISTC’s support. Local computer net, Internet-enabled has been installed.

In recent years SRCAM focuses on biosafety and biosecurity of the center laboratories. With the support of DTRA program, the vivarium of the department of especially dangerous infections was reconstructed, the ventilation system of some laboratories was improved. The system of physical protection was modernized; the second boundary of the electronic signal system and the system of round-the-clock video control of the protected perimeter was installed. This work will be continued to improve the systems of accounting, control and maintenance of physical safety of biological materials.

Thus, SRCAM scientific potential was formed during more than 20 years for solving special tasks in the field of molecular biology and genetics with any agents, was kept and substantially increased including with ISTC’s support. The staff of our center consists of physicians, biologists, biotechnologists, veterinaries, specialists on plant protection, chemists and biochemists, physicists, engineers, etc, and most of them studied special courses of especially dangerous infections and have 15-25-year practical experience in this field.

The laboratory complex is provided with own museum collection of strains and genetic construction and also technical facilities for xero- and cryo- preservation of biological material. The collection provides for carrying-out of scientific research and industrial program of the Center.

Scope of activity ;

·  Study of molecular bases of pathogenicity and immunogenicity of highly dangerous agents and socially important infections, including genetically modified variants (basic researches);

·  Design of new means of indication and differential diagnostics of biological agents in laboratory samples and environment objects;

·  Improvement of traditional methods and development of alternative ones of prophylaxis and treatment of bacterial infections;

·  Study of mechanisms and routes of targeting delivery of biologically active substances to injured cells and tissues;

·  Development of new immunobiological preparations for medicine and veterinary science;

·  Development of microbiological means to protect the environment against anthropogenic pollution;

·  Development of microbiological means for plant protection;

·  Production of diagnostic nutrient media.

Production capacity is more than 75-80 tons of dry nutrient media a year, and it consists of about 50 % of Russian market requirements. Some preparations for diagnostics of especially dangerous and socially important infections are developed and are produced in Russia, only in SRCAM.

Today the total staff of our facility is 758 person, including 105 Doctors of Science and PhDs. The middle age of scientists is 51 years. For over two decades of our center 47 doctorial and 256 Ph.D. theses have been written. There are about 8000 scientific publications, more than 200 inventor’s certificates, 96 patents.

The center is fully involved in scientific activity. In recent 5 years two scientific workshops (All-Russian and International ones) were held. Some international seminars on problems of medical biotechnology, biological and ecological safety and refresher courses for personnel are annually organized.

SRCAM cooperates with institutes of the Russian Academy of Science, Ministry of Health, Ministry of Defense of RF and other organisations.

The center has obtained the significant experience of international cooperation. Our partners are scientific organizations in USA, countries of Europe, in Japan, China, Vietnam, Thailand, etc. Since 1995 we have made more than 60 international research contracts. Researchers of the Center actively participated in the international seminars, workshops and congresses, including the annual conferences, organized by American and European biosafety communities. More than 380 times our specialists have visited many foreign research centers and institutions (the USA, Great Britain, Germany, France, Sweden, Italy, Japan, China, etc.) to discuss results of joint researches, exchange results and acquire new experience.

Thus, SRCAM has great research-and-production potential for internal and international cooperation in the field of biosafety. There are a lot of many problems in this field. The national rules of work with dangerous microorganisms often are not be coordinated. It extremely complicates scientist work in many countries. There are no intergovernmental and association agreements in the field of joint counteraction to bioterrorism threat. The mechanism of the control of the Convention of 1972 on prohibition of the biological weapons and etc. [3,4] is practically blocked.

It is obvious, that political, organizational, legal, scientific, economic, medical, information measures should be based on results of objective scientific research of this problem. Our scientists, having knowledge of the basic problems of biological safety, are the main property of our center. Technical and technological opportunities allow to plan both experimental, and analytical, educational, information work in this field. [5-9].

As the analysis of literature shows, Russia is high on creation of national normative-legal base in the field of biosafety. Using, transferring, joint information using, mechanisms and reports of risk estimation, gene-engineering activity, work order with genetically modified organisms and products are regulated. In this report there is no opportunity to characterize these documents in detail. We have included only some useful references without comments in the list of the literature [10-40]. In general, practically all of them demand harmonization with similar documents of other countries and should be improved constantly according to achievements of science and practical needs. The State Research Center for Applied Microbiology can participate in this work with close cooperation with Russian and international organizations.

Литература:

1.  Ремнёв Ю.В., Самохвалов Е.И., Юферов В.П., Урываев Л.В., Бабаева П.В., Боровик Р.В. Способ выделения РНК-зависимой ДНК-полимеразы. А.с. №1108105 по заявке №348063 от 05.08.82

2.  Pomerantsev A.P., Staritsin N.A., Mockov Yu.V., Marinin L.I. Expression of cereolysine AB genes in Bacillus anthracis vaccine strain ensures protection against experimental hemolytic anthrax infection, Vaccine , vol.15, No.17/18, pp. 1846-1850, 1997.

3.  Игнатьев О.Б. О роли Конвенции о запрещении биологического оружия в нераспространении оружия массового поражения // Проблемы биологической безопасности Российской Федерации: Сборник докладов I Российского симпозиума по биологической безопасности (23 октября 2003 г., г. Москва) [Электрон.ресурс].- 2003.- Режим доступа: http://www.bio.su/ru.htm или http://www.bio.su/igr.htm [847] - кат04 + ст04.

4.  Евстигнеев В.И. Проблемы обеспечения биологической безопасности России // Проблемы биологической безопасности Российской Федерации: Сборник докладов I Российского симпозиума по биологической безопасности (23 октября 2003 г., г. Москва) [Электрон.ресурс].- 2003.- Режим доступа: http://www.bio.su/ru.htm или http://www.bio.su/evr.htm [847] - кат04 + ст04.

5.  Кондрик Е.К. и др., Проблема биологической безопасности/ Кондрик Е.К., Н.Н.Ураков, В.Я.Волков, Н.А.Старицын, Л.И.Кавызина, Е.И.Кобзева// Проблемы социальной гигиены, здравоохранения и истории медицины.-2003.-№5.-С.24-27. [847] – кат04.

6.  Кондрик Е.К.и др. Аналитическое обоснование концепции биологической безопасности/ Кондрик Е.К., В.Я.Волков, Л.И.Кавызина, Н.А.Старицын, Н.Н.Ураков.-М.(:ФГУП «Производственно-издательский комбинат»), 2003.-64 с., ISBN 5-201-14513-2, [847]– кат04.

7.  Волков В.Я. и др. Роль ГНЦ ПМ в интегрированной системе биологической защиты / Волков В.Я., Ураков Н.Н., Старицын Н.А., Кавызина Л.И., Кондрик Е.К.// Биотехнология: состояние и перспективы: Материалы 1-го Международного конгресса (Москва, 14-18 окт.2002 г.).-М.: ЗАО ПИК «Максима», РХТУ им.Д.И.Менделеева,2002.-С.255-256. [83.4] – кат04.

8.  Старицын Н.А. и др. Физическая и биологическая безопасность на объектах, работающих с опасными и особо опасными патогенами/ Старицын Н.А., Волков В.Я., Тюрин Е.А., Стеганцев Н.П., Дьякова Т.А., Маринин Л.И. // Проблемы биологической безопасности Российской Федерации: Сборник докладов I Российского симпозиума по биологической безопасности (23 октября 2003 г., г. Москва) [Электрон.ресурс].-2003.- Режим доступа: http://www.bio.su/ru.htm или http://www.bio.su/str.htm [847] - кат04 + ст04.

9.  Волков В.Я., Кондрик Е.К., Кавызина Л.И. К вопросу о национальной биологической безопасности ( В печати, ж. «Молекулярная медицина», 2004) [847] кат04 + ст04.

Legislative foundations of biosafety:

10. Основы государственной политики в области обеспечения химической и биологической безопасности Российской Федерации на период до 2010 года и дальнейшую перспективу // Российская газета [Электрон.ресурс].-07.04.04.- Режим доступа: http://www.bio.su/press_2004apr_004r.htm [65] -кат03, кат32 + ст03

11. Концепция микробиологической безопасности Российской Федерации (Рассмотрена 24 окября 1995 г.)/ Онищенко Г.Г., С.П.Андреев, Ю.А.Белов и др.// Экологическая безопасность России. Вып.4. Материалы Межведомственной Комиссии Совета Безопасности (сентябрь 1995 г.-апрель 2002 г.).-М.,2002.-(521 с.) С.32-40. Обсуждение и решение .-С.40-44. [847] – кат04

12. Короткин Л.М. Национальная нормативно-правовая база, обеспечивающая выполнение международных обязательств Российской Федерации по контролю за экспортом продукции биологического профиля двойного назначения // Проблемы биологической безопасности Российской Федерации: Сборник докладов I Российского симпозиума по биологической безопасности (23 октября 2003 г., г. Москва) [Электрон.ресурс].- 2003.- Режим доступа: http://www.bio.su/ru.htm или http://www.bio.su/kor.htm [65] - кат03 + ст03

13. Пименов Е.В. Система микробиологической безопасности как часть системы национальной безопасности России // Сб. науч. тр., посвященный 75-летию НИИ микробиологии МО РФ.- 2003.- С.5-7 [847] кат04

Use, transfer, joint information use

14. Доктрина информационной безопасности Российской Федерации [Электрон.версия]. -Утверждена Президентом Российской Федерации В.Путиным 9 сентября 2000 г.; № Пр-1895.-Режим доступа: http:www.serv.gov.ru/Decree/2000/09-09.html [65] – кат03

15. Закон РФ. О государственной тайне. №5485-1 от 21.07.1993 г.; Изменения и дополнения.- №131-ФЗ от 06.10.1997 г. [65] кат03

16. Дюк В.А., Миленина Е.В. Информационная безопасность// Вестник МАПО.- 2004.- № 2, февраль.- С.6 [168] кат02б