SEZ "Technopolis Moscow" began production of "cellular" medicinal products

Technopolis Moscow SEZ Launches Production of Cell-Based Medicines

The SEZ resident Akrus Biomed has begun producing pilot batches of advanced cell-based medicines for clinical trials. These innovative therapies, containing cultured patient cells, are intended for the treatment of critical burns, joint damage, and spinal cord injuries. They are the first of their kind in Russia. The news was announced by Maxim Liksutov, Deputy Mayor of Moscow for Transport and Industrial Development.

“On the initiative of Moscow Mayor Sergey Sobyanin, biotechnology is rapidly developing within the capital’s SEZ. More than 20 enterprises are implementing innovative solutions in this field. Eight offset contracts for the production of advanced medicines have already been signed with the city. One of the residents, specializing in medicines based on human somatic cells, has started producing samples for clinical trials in cooperation with three of the country’s leading biomedical research centers. This marks an important stage in the development of high-tech treatment methods in Russia, particularly in tissue engineering — a breakthrough area of personalized regenerative medicine,” Liksutov explained.

Currently, only a handful of enterprises in Russia hold licenses to manufacture advanced therapy medicinal products (ATMPs), which can be used to treat a wide range of severe conditions — including critical burns, pressure ulcers, trophic ulcers (such as diabetic foot), chronic wounds, musculoskeletal disorders, nervous system injuries, and certain cancers.

In May 2024, Akrus Biomed became the first Moscow-based company licensed by the Ministry of Industry and Trade to produce ATMPs for clinical research purposes, as no such medicines have yet been approved for commercial use in Russia. The facility operates according to GMP standards, enabling Russian developers of cell-based and tissue-engineered products to create samples for all phases of clinical trials using the company’s production capacities.

According to Anatoly Garbuzov, Moscow Government Minister and Head of the Department of Investment and Industrial Policy:
“The company is also preparing to produce biological and dermal skin equivalents, based on research from the Koltsov Institute of Developmental Biology of the Russian Academy of Sciences, and is awaiting approval to begin clinical trials. The cultivated skin will be supplied to clinics in Moscow and other Russian cities. The facility’s production capacity will reach up to 70,000 units annually, with investments exceeding 470 million rubles.”

The first ATMP samples produced are already undergoing clinical trials.

“Clinical studies have begun on three cell-based medicines designed to treat spinal cord injuries, joint damage, and critical burns. The trial samples were produced by Akrus Biomed at the Technopolis Moscow SEZ. These are the first trials of their kind in Russia. Our team is also sharing its expertise with students of the Pirogov Russian National Research Medical University, where the country’s only Department of Cellular Biomedicine operates. Additionally, we conduct advanced training programs in cell and gene therapy for specialists from public institutions at our site,” said Yuri Sukhanov, Deputy Director of Akrus Biomed.

The company has been developing its production base at the Pechatniki site of the SEZ since 2019.

“Choosing this location was a strategic decision, given the advantages of the Moscow SEZ — first of all, ready-to-use infrastructure with access to utilities, which allowed us to establish production facilities meeting international GMP standards. SEZ resident status also provides a wide range of tax benefits, enabling greater reinvestment into business development. The company continues to work on next-generation cell-based products — promising therapies for post-heart attack and post-stroke conditions, multiple organ failure, chemotherapy rehabilitation, as well as treatments aimed at active longevity,” summed up Gennady Dyogtev, CEO of the Technopolis Moscow SEZ.