Recent biotechnology developments and trends in the Russian Federation .

The BIO2020 strategy was followed by a number of high level documents and decisions in the areas of biotechnology and bioeconomy (Table 1). The most important among them was the establishment of a special interministerial steering group on biotechnology development chaired by the Deputy Prime Minister to coordinate all activities and initiatives in the field and the adoption of the Roadmap “Development of biotechnology and genetic engineering” (July 2013) [8] and “Prognosis for Scientific and Technological Development of Russia to 2030” with a special section dedicated to biotechnology (2014) [9]. In February 2014, the Presidium of the Presidential Council for Economic Modernization and Innovative Development under the chair of the Prime Minister adopted a number of important decisions and measures aimed to support biotechnology development in Russia, including the support of R&D. More recent government documents directly affecting the biotechnology area include a Complex target programme for the Russian Federation: “R&D support for activities in creating domestic crop and livestock gene banks and plant protection products in order to promote competitive agricultural production by Russian producers and in developing technologies for cultivation and storage of such products for 2016-2025” [10], legislation regulating turnover of genetically modified organisms (2016) [11] and the “Strategy for the Scientific and Technological Development of Russia to 2030” (2016) [12].

Instruments available for R&D and business development

R&D support

Until recently, the lion’s share of R&D funding in the Russian Federation came from the state. Business is not as active in supporting R&D as in other technologically developed countries and contributes (by different estimates) only 10 to 25% of R&D costs, compared to >50% in leading economies. Biotechnology is not an exception. Fundamental research in Russia is mainly concentrated within the institutions of the Russian Academy of Science; universities, with the exception of leading schools such as Lomonosov Moscow State University, still play a minor role. In addition to direct budget subsidies channelled to scientific research institutions and universities, R&D support is provided through specialized government foundations such as the Russian Foundation for Basic Research (RFBR), Russian Science Foundation (RSF) and grant funding offered by the Ministry of Education and Science. A number of specialized programmes and grants in the field of biotechnology have been launched by these funding bodies over the past few years. These include specialized calls for industrial and agrobio-technologies and food sciences. Through the Ministry of Education and Science, Russia supports the participation of Russian teams in all areas of Horizon 2020 activities, as well as bilateral specialized calls (e.g., the German-Russian grant programme on industrial biotechnology). The Russian Fund for SME support participates in a number of ERANets in the area of biotechnology.

Innovations and business development

Modern Russia has a well-developed environment for promoting innovation and supporting start-ups. Institutions such as RosNano, Skolkovo Foundation and the Agency for Strategic Research have radically changed the innovation landscape over the past decade. Red pharma biotechnologies were of course the major and primary emphasis of these foundations in the area of life sciences. However, in recent years the scope of activity and mandates of these organizations have been adjusted to consider recent government initiatives in support of agrobiotech.

The Skolkovo Foundation, which was established in 2010 with the major goal to create a sustainable ecosystem of entrepreneurship and innovation, widened the mandate of its Biomedical division to include agrobiotechnologies in a major step towards diversification of the bioeconomy. Renewable energy was always on its agenda. This trend was followed by the other innovation pillar, RosNano, which also expanded its mandate to support biotech projects.

A major breakthrough came after the Presidential address to the Parliament in December 2014, where the President called for a National Technology Initiative (NTI) [13]. NTI, with a planning horizon up to 2035, will include systemic solutions for the definition of key enabling technologies to ensure a Russian presence in the global markets of the future, as well as necessary changes to rules, regulations and effective measures of financial and human resources development to achieve the set goals. NTI is targeting-fast growing technology companies that are ready to absorb new developments; new creative teams; leading universities; research centres; major business associations; development institutions; expert and professional communities and engaged ministries. NTI uses a bottom-up approach and relies on the activity of stakeholders. It is currently structured into nine Nets, three of which—HealthNet, NeuroNet and FoodNet—are directly associated with biotech. Each Net develops a concept and a road map that are evaluated by the government commission under the chair of the Deputy Prime Minister. When approved, the road map is filled with projects that facilitate implementation of the goals of the particular Net. Each project is evaluated on an individual basis by a special high-ranking board; if approved, the Net receives both federal and business funding (average ∼$1 to 5 M). FoodNet contains a set of declared priorities, including agrobiotechnologies, novel sources of renewable biomass, functional foods and feeds and “precision agriculture”. Precision agriculture involves the planting of seeds and the application of fertilizers and plant protection agents in accord with non-uniformity of arable lands and demand for crops; automation of agricultural production; and accumulation and cataloguing of all data relevant to agriculture (agriBigData). This field is of special interest and could become an important tool in developing elements of the bioeconomy in Russia.

Major current trends

The growth of tensions in Russia-West relations after 2014 was a major event that had a profound impact on the development of the Russian biotech sector and resulted in economic anti-Russian sanctions and retaliatory measures from the Russian Federation. These tensions affected all sectors of the economy but were probably most profound in the agricultural sector. Because of the embargo on selected food imports imposed by the Russian government and the disappearance of competitors from local markets, the national agricultural producers were able to increase their manufacturing. Russian agriculture was one of the beneficiaries of the “sanction war” and showed steady growth up to 4% per year in the past two years in a background of overall decreasing GDP.

Substitution of imported goods and services with local ones is of the imperatives of the modern Russian economic situation. The dependence of some sectors of the Russian economy on imports remains critical, and thus provision of domestic technologies, services, competencies and goods is a major government task offering new opportunities to local companies in all the sectors of the economy, including the agroeconomy.

The concentration of agricultural production into large agroholdings that occurred in the past 15-20 years facilitated introduction of modern agrotechnologies, mainly of western origin, and resulted in a dramatic growth of productivity in all sectors of agricultural production. In the past few years, Russia has become the world’s largest grain producer, with an estimated current surplus of grain of 30-35 million tons and a forecast of 50 million tons over the next decade. Such tremendous overproduction of grain, relatively low international grain prices and the resulting competitive economic situation dictate the necessity to establish local industry to process grain into high value-added products (e.g., modified starches, amino acids). However, an increase in agricultural output has another facet, namely the accumulation of enormous amounts of waste that demand proper handling and utilization. Waste, in particular agricultural waste, is a burden for environmental protection policies but at the same time provides another set of incentives and opportunities to increase agricultural production efficiency through recycling, increases in energy efficiency, extraction of valuable substances (e.g., proteins from waste) and transformation of waste into value-added products such as fertilizers.

Taken together, the critical dependence on imports (in particular, seeds, breeding cattle and feed components) threatens national security and a relatively short window of opportunities for local produce. This motivated the abovementioned set of measures suggested and introduced by the federal government: the recently adopted complex target programme of R&D support of agricultural production [10] and reorientation of the so-called Institutions of Development (e.g., Skolkovo, RosNano, Russian Venture Company, Agency of Strategic Initiatives) towards biotechnology and its applications in the agricultural sector.

Thus, agrobiotechnologies and the agricultural sector as a whole enjoy major attention and support from the state. The main priorities are outlined in high-level presidential or government documents and include a comprehensive set of measures to stimulate the creation of new local crop varieties and animal breeds to overcome a critical dependence on imports. It also implies support of industrial biotechnology sectors servicing the agricultural sector: the production of plant protection agents, feed additives including enzymes and amino acids, biofertilizers, growth stimulators and veterinary and feed antibiotics. Environmental protection, recycling and valorisation of waste from the agricultural and food industries are also of extreme importance.

Legislation and Standards

Another important aspect of the Russian biotechnology agenda is its position towards GMOs, which is rather conservative and determined by extensive legislation, regulating such areas as safety testing procedures, labelling, use for R&D purposes and release into the environment. The first set of regulations, approved in the mid-1990s, set up a general framework for safety testing and admission of GMO-containing feed and food in local markets. However, the legislation has important gaps that precluded the building of a comprehensive regulatory system at that time.

Attitudes towards GMO in Russian society are contradictory. The majority of academic experts are in favour of loosening regulatory restrictions while maintaining all the strict barriers associated with safety testing and release into the environment. However, the general public opinion, stimulated by the media, is rather hostile. Thus, in 2016, a new set of GMO regulations [11] was adopted by the State Duma that effectively banned GMO crops from Russian fields and GMO-containing products from Russian markets. It remains to be seen how GMO legislation will affect implementation of other measures intended to stimulate R&D in agrobiotech (e.g., creation of new varieties and new breeds) and agricultural produce and whether this legislation will also affect new technologies for gene manipulation, including CRISPR/CAS.

In contrast, organic agriculture received very positive responses from legislators. In 2015, the national standard GOST R 56508-2015 on “Organic production. Regulations for production, storage, transportаtion” was adopted and a number of federal laws (e.g., “Rules for production and turnover of organic goods”) and amendments to existing ones are under discussion and currently at different stages of preparation.

A “Best Available Techniques” (BAT) instrument, similar to the Best Available Techniques Reference documents created by the EU, is now available in the Russian Federation. BAT is considered an important instrument for state regulation and harmonization of environmental and industrial policies. The Russian Ministry of Industry and Trade is overseeing this activity, which is implemented by the Federal Agency “Rosstandart” and the special Bureau of BAT. Sectoral lists of BAT are currently under development, including agriculture, processing of organic raw materials and minimization of industrial emissions. Biotechnologies could play a substantial role to achieve these environmental objectives and reduce pollution.

The Ministry of Labor and Social Protection, in cooperation with the interested businesses and TPs, is developing professional standards in the field of biotechnology that will improve management of human resources and provide the basis for the development of related educational standards. Among the documents under development are the standards for “Quality control specialist in biotechnological production of substances for crop production”, “Specialist-technologist in biotechnological production of detergents and cleaning agents”, “Specialist-technologist in the field of environmental technologies”, “Specialist-technologist in the production of paintwork coatings, biochemical dyes and household products”, “Specialist in transportation, warehousing and storage of biochemical products”, “Quality control manager in biotechnological production”, “Specialist-technologist in the field of bioenergy technologies”, “Specialist in organization of the production in the field of bioenergy and biofuels”, etc.

To coordinate all the standardization activities in the biotech area that were previously dispersed among various bodies, the special Technical Committee No. 326 “Biotechnology” was established in 2014 under the general supervision of the All-Russian Research Center of Standardization, Information and Certification of Raw Materials, Materials and Substances, NIISMT.

Regional initiatives and major biotech projects

While R&D activities in biotech are mainly concentrated in the major scientific and educational centres of Russia, including Moscow and the Moscow region, Saint-Petersburg, Novosibirsk and Tomsk, business activity and implementation of biotechnological projects is located in the provinces, clustering in regions in the south of Russia and Siberia where there are available, accessible raw materials, e.g., grain, agricultural waste and wood waste.

Regions

Several biotechnology clusters have been formed in the Russian Federation or are still under formation. The majority specialize in pharma and red biotechnology, e.g., clusters situated in Saint-Petersburg, Kaluga, Novosibirsk, Yaroslavl and Tomsk. However, a number of Russian regions that have actively introduced innovations have declared their intention to develop biotechnology clusters and/or engineering centres specializing in industrial and agrobiotechnologies. The most advanced are the Republic of Tatarstan, Republic of Bashkortostan and the regions of Altai, Novosibirsk, Krasnodar, Rostov-on-Don, Belgorod and Kirov. In cooperation with local governments, universities and business communities, an R&D and pilot infrastructure for the development of industrial and agrobiotechnologies has been established, and training programmes have been initiated and industrial facilities have been launched. The current emphasis is on the development and small-scale production of feed additives, biofertilizers and biological plant protection agents.

However, there are much more ambitious initiatives. A number of Siberian regions, such as the Novosibirsk, Tomsk, Kemerovo, Omsk and Irkutsk regions, and Altai and Krasnoyarsk Krai, with a total output of biotech products worth ∼$500 M united their efforts under the Siberian biotechnology initiative, a cross-regional programme that brings together businesses and R&D institutions operating in the biotechnology and pharmaceutical sectors. The proclaimed agenda is the rehabilitation and modernization of the biotechnology industry in Russia, based on the potential of Siberian scientific-technological, industrial and educational complexes in the following sectors: biotechnology for agriculture, pharmaceuticals, food industry, forestry and environmental protection.

Selected biotechnology projects

No single industrial biotechnology plant was launched in Russia in 1990-2010. The first one, located in the Tambov region and specializing in the production of industrial technical enzymes, was started in 2013. It has an output of up to 1,000 tons per year and a comprehensive product list comprising enzymes used as feed additives. The enterprise relies on proprietary production strains developed in Russia.

Due to enormous surplus of grain, which is mainly clustered in the Southern parts of European Russia and some regions of Southern Siberia, the construction of grain processing plants is high on the agenda. A plant producing lysine—an indispensable amino acid used as a feed additive— was erected in the Belgorod region. The plant is rated for processing 250 thousand tons of grain with production of 55 thousand tons of lysine sulphate. It uses proprietary strains and technology developed by the GNIIGenetik, a leader in the field of genetic engineering of industrial microorganisms. Another lysine plant rated for processing of 120 thousand tons of grain is under construction in Siberia in the Tumen region and will be operational in the coming months. Another lysine plant that will process 250 thousand tons of grain is under construction in the south of Russia in the city of Volgodonsk. It is a joint venture between Russian investors and Evonik of Germany, which supplies the technology. Thus, when all the projected lysine plants are operative, they will meet Russian demand for lysine and also supply this amino acid for export.

The EastAgro group of companies, in cooperation with the Rostech State Corporation, is developing a project in the Lipetsk region for the production of inulin and fructooligosaccharides from topinambur. BioTechnologies is implementing an ambitious project for the production of protein concentrates from oilseeds (sunflower). A plant in the Altay region capable of processing 23 thousand tons of sunflower meal and producing 6,000 tons of protein concentrate, 5,400 tons of saccharide syrup and 12,000 tons of energy pellets was launched in 2015. Similar plants are under construction in the Voronezh region and in the Republic of Tatarstan. The Titan group of companies, specializing in chemical products, is diversifying its activities into the agro- and biotech sectors. A chemical-biotech cluster has been formed in the Omsk region. The company targets production of ETBE using bioethanol produced from grain.

Summary

Since 2010, Russia has taken systematic measures to create an infrastructure for developing biotechnology and elements of the bioeconomy. A number of high-level documents were adopted, including the comprehensive BIO2020 program, outlining general approaches to biotechnology development in the Russian Federation. Important amendments to federal legislation either have been already introduced or are under discussion.

The development of biotechnology is considered a national priorities that will shape the future of the Russian economy to a major extent. The trend was initiated during a long period of economic stability in the Russian Federation, stimulated by high oil/gas prices. Another impulse for further development in the current circumstances is the demand for self-sufficiency and independence of the local economy should economic sanctions and counter-embargoes occur.

The major growth points in the bioeconomy are located within the sectors of agrobiotechnology, food production and specialized small-scale chemicals. Thus, the trajectory of biotechnology development in the Russian Federation is specific and differs, sometimes considerably, from global trends.

© 2017 Published by Elsevier B.V.