The first license for production of BMСP was obtained.

The first license for production of BMСP was obtained.

Licensing of BMСP production was one of the key problems in bringing such products to the Russian market. We have published several articles covering the requirements for the applicant of the license (https://beawire.com/ru/biomedical-cell-products/licensing-of-biomedical-cell-products-production-activities/https://beawire.com/ru/biomedical-cell-products/licensing-of-biomedical-cell-products-production-activities/), as well as the success of some companies in licensing the production of BMСP (https://beawire.com/ru/2019/04/08/bmcp-problems-and-prospects-of-development-in-russia/).

According to the Ministry of Industry and Trade, Roszdravnadzor issued the first license for the production of biomedical cell products. The recipient was the Russian scientific and production company of the full cycle “Generium” (license № FS-99-05-000001). License issued on 23.04.2020 indefinitely and applies to the following premises:

Source: https://www.roszdravnadzor.ru/services/licenses

It is necessary to say that obtaining this unique license is a kind of breakthrough for this field, showing that production of BMCP in Russia is possible.

Generium plans to develop and produce a number of autologous, allogenic and combined BMCPs, as well as personalized therapy and diagnostics. In addition, the company’s plans include the development of drugs designed to combat the pandemic coronavirus infection (COVID-19).

The drugs being developed will be part of the portfolio of regenerative medicine, one of the booming fields of medicine. Its main task is to replace and/or restore the function of disease-affected organs or tissues in cases where the body’s own regenerator capabilities are unable to provide repair or healing of the defect.

This may be relevant for the therapy of many systemic diseases and severe life-threatening conditions, such as acute myocardial infarction or acute respiratory distress syndrome, which is one of the major complications with severe current COVID-19.

It should be noted that the company is already actively involved in the fight against the COVID-19 pandemic and together with the group of companies “Medico-Biological Union” developed and brought to the market 2 diagnostics:

  1. Test systems for detection of antibodies to coronavirus SARS-CoV-2 (“Antigma®”) designed to determine the level of immunoglobulins of “rapid” response, such as A (IgA) or M (IgM), as well as immunoglobulins indicating the formation of a persistent immune response G (IgG) by enzyme-linked immunoassay.
  2. Reagent set for SARS-CoV-2 RNA detection by loop isothermal amplification (“SARS-CoV-2 RNA-screen isotherm”).

 

References:

  1. https://minpromtorg.gov.ru/press-centre/news/#!vydana_pervaya_v_rossii_licenziya_na_proizvodstvo_biomedicinskih_kletochnyh_produktov
  2. http://www.generium.ru/about/press_center/Media_about_us/vydana-pervaya-litsenziya-na-vypusk-biomeditsinskikh-kletochnykh-produktov/
  3. https://gmpnews.ru/2020/04/pervuyu-licenziyu-na-proizvodstvo-biomedicinskix-kletochnyx-produktov-vydali-v-rf/