This licence is the first of its kind in Russia. According to experts, it will help make a breakthrough in the field of regenerative medicine. The company that received it plans to develop and produce a number of autologous, allogeneic and combined BMCPs, as well as products for personalised therapy and diagnostics. They can also be beneficial in the fight against the COVID-19 pandemic.
This refers to replacement or functional restoration of human tissue and organs that have been affected by the disease and have lost their own regenerative abilities. It is necessary when the body cannot heal the defect on its own. First of all, these methods are intended for the treatment of severe socially significant diseases with a high level of disability. Also, the BMCP manufacture will solve the problem of filling therapeutic niches with high unmet needs.
'Cellular technologies are the most modern tool for personalised medicine', emphasised Sergey Tsyb, First Deputy Minister of Industry and Trade of the Russian Federation. 'Thanks to unique infrastructure of Russian biotechnological plants, they become the centre of attraction for the international pharmaceutical industry representatives and scientists from various fields of science, including doctors, biologists, physicists, engineers, chemists, IT specialist and mathematicians. It also allows for quick resolution of the most complex issues Russia faces in the field of its citizens healthcare'.
Granting of this licence means that the tissue engineering industry is becoming a reality. The main segments of this market are precisely BMCP: tissue and cell therapy products. They are cultured human cells.
It is not even a new technology, but a different medicine in general. This opinion was expressed by Vsevolod Tkachuk, member of the Russian Academy of Sciences, Dean of the Faculty of Fundamental Medicine, Lomonosov Moscow State University. According to him, cell modification and genome-editing methods are actively developing.
Vsevolod Tkachuk explained that there is a prospect for a new therapy development, which will be aimed not only at regulating living cells, but also at growing new cells, tissues and structures in our body. With the first manufacturing licence, we understand that the regenerative medicine has prospects of becoming a new effective branch of the Russian healthcare system for the treatment of the most severe human diseases that cannot be cured by other products.
Studies in this area are the focus of attention of both Russian research centres and leading clinicians worldwide. Interestingly, that the first R&D site was created in Russia in 2014. There were no analogues in Russia; therefore, during its construction, the world experience was taken into account. Hence, it meets strict international standards.
As Dmitry Kudlay, prof., General Director of Generium JSC, noted, the licence for BMCP manufacture offers Russia opportunities to implement a number of complex advanced projects, including those aimed at combating the novel coronavirus. According to the expert, Russia enters the era of cell technologies.
Dmitry Kudlay said that world biotechnologies in the field of regenerative medicine are at the stage of explosive growth and investment. Today, the ability of a person to manage intra- and extracellular processes helps create technologies for solving the most challenging issues in the treatment of patients with serious illnesses or injuries.
Source: Rossiyskaya Gazeta