About cluster

Cluster «Pharmaceutics, biotechnologies and Biomedicine» Kaluga region was formed in 2011 and in March 2012 was legally issued in the form of ASSOCIATION «Kaluga pharmaceutical cluster».

Industry cluster specialized– conducting preclinical and clinical studies, development, synthesis and implementation into production of pharmaceutical substances and radiopharmaceuticals, manufacturing of finished pharmaceutical products (FPP) and pharmaceutical substances, infusion solutions and parenteral nutrition.

The growth in the number of employees
participant organizations
cluster
9 043 people at the end of 2018
Growth in investment costs
of participating organizations

less costs for acquisition of land, construction of buildings and supply of utilities.
4 500 000 000 ₽ at the end of 2018
The growth of the volume shipped by the organizations own production,
as well as works and services performed by own forces.
52 900 000 000 ₽ at the end of 2018
Open 10 factories of a full cycle according to GMP standards with a total investment of:
52 700 000 000 ₽ at the end of 2018
The cluster members produced 90 tons of pharmaceutical substances
The number of items of finished pharmaceutical products:
increased to 154 names at the end of 2018
The volume produced by members of the cluster products
as well as works and services performed by own forces
12% of GRP at the end of 2018

The cluster’s mission and development goals

Mission
Capacity-building assistance in relation to scientific, productive and social development of cluster members through cooperation and innovation.
Objectives
Establishment of a high-tech scientific and industrial complex in the Kaluga region which is territorially interconnected as well as complementary production facilities and infrastructure organizations to develop, introduce and manufacture innovative next-generation pharmaceutical and medical products: finished pharmaceutical products, pharmaceutical substances, radiopharmaceuticals, medical products in accordance with GMP designed to enhance national drug safety in the key socially important areas dealing with the provision of Russian citizens with essential drugs, biomedical technologies and means of diagnosis and treatment.
Task
Being among the top three leaders in Russia measured by production volume of innovative pharmaceuticals and finished pharmaceutical products with a total of at least 10% share of the Russian pharmaceutical market by 2020.

Support for the cluster at the federal and regional levels.

According to the RF Government Resolution No. 188 of March 6, 2013, the cluster was declared a pilot innovative territorial cluster of the Russian Federation.

In October 2016, following a competitive selection process undertaken by the Ministry of Economic Development of Russia, the cluster was included in the list of innovative clusters - participants in the priority project of the Ministry of Economic Development of Russia “Development of Innovative Clusters – World Leaders in Investment Attractiveness”. In December 2016, the Ministry of Economic Development and Trade of the Russian Federation and the Government of the Kaluga Region concluded an Agreement on support for the development of innovative territorial cluster in the Kaluga Region – “Pharmaceuticals, Biotechnology and Biomedicine”.

Development of the cluster is carried out in accordance with the Strategy for the Socio-Economic Development of the Kaluga Region until 2030, the Strategy for the Development of an Innovative Territorial Cluster “Pharmaceuticals, Biotechnology and Biomedicine until 2020 approved by the Government of the Kaluga region on September 19, 2016, the Program for the Development of Innovation Cluster – “Pharmaceuticals, Biotechnology and Biomedicine” – in the Kaluga region approved by Resolution No. 488 of the Kaluga Regional Government of September 20, 2013.

Key activities

Development and manufacture of finished pharmaceutical products and pharmaceutical substances

Development and manufacture of finished pharmaceutical products and pharmaceutical substances

The launch of its own development, creation and maintenance of the original brands.

  • Development and validation of the synthetic scheme, process optimization, standard operating time (reproducible) series.
  • Development of the project specification of analytical methods and the project enterprise Pharmacopoeia article.
    Justification of the specification and validation of analytical methods APS.
  • The study of the stability of the ASF in storage. Determination of the shelf life of the ASF. series analysis protocols.
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Nuclear medicine

Nuclear medicine

The planning and development of infrastructure for the provision of medical services and production, taking into account the needs of the population.

One of the activities of SC «Rosatom» It is the development of nuclear medicine (medical diagnostics and radiotherapy used in the treatment of cancer). In cooperation with the Federal Medical-Biological Agency of Russia and the leading manufacturers in the domestic industry has begun reconstruction of the entire production of medical complex of isotopes to medical care on the domestic equipment.

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Biotechnology

Biotechnology

Creating a new biologically active substances and drugs in medicine.

The use of the industrial production of microorganisms or their enzymes, providing technological process, known since ancient times, but systematic research allowed to significantly expand the arsenal of methods and means of biotechnology.

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Manufacture of medical equipment and medical products

Manufacture of medical equipment and medical products

Ensuring the quality and safety of medical devices manufactured, development of quality control mechanisms.

A wide range of products for security of medical, rehabilitation, diagnostic, preventive measures, care for the sick and disabled. It includes supplies, tools, appliances, furniture and other products. For medical devices do not include funds that have a «pharmacological, immunological, genetic or metabolic effects on the human body ».

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