By 2030, the creation of a production facility for autologous cell preparations for the treatment of rheumatic diseases is planned in Novosibirsk. The manufacturing will be organized directly within the clinic. Maxim Korolev, Director of the Research Institute of Clinical and Experimental Lymphology (NIIKEL), shared details of the project at a TASS press conference on February 6.
Siberian Consortium
The project is being implemented within the framework of the “High-Tech Bioeconomy” World-Class Research Center (NCMU) under the auspices of the Kurchatov Institute. In 2025, the Institute of Cytology and Genetics SB RAS received a grant to adapt CAR-T technologies for the therapy of rheumatic diseases.
A consortium has been formed to implement the project. In addition to NIIKEL, it includes:
- Research Institute of Fundamental and Clinical Immunology;
- Institute of Molecular and Cellular Biology SB RAS;
- Novosibirsk State University (NSU);
- A number of industrial partners.
“Modern biomedical science is based on the work of large teams. We are located at different sites but are united by one social goal — the development of new diagnostic and treatment methods,” noted Maxim Korolev.
“Hospital Exemption” Model
A specific feature of the project is operating under the “hospital exemption” mode. This allows the medical institution to manufacture biomedical cell products for specific patients, bypassing the classic industrial cycle.
“Hospital exemption is a special production cycle where the medical and preventive treatment facility not only provides the patient with medical technologies but also produces all technological elements. That is, a small pharmaceutical factory will be built inside the NIIKEL clinic, which produces the product, monitors all its parameters, and provides the patient with new drugs. Today, this is a common practice in the production of complex medical technologies, where cells of a specific patient are needed to create the drug, which will be modified by the pathological agent of the same patient.”
— Maxim Korolev, Director of NIIKEL (branch of ICG SB RAS)
Role of NSU
Novosibirsk State University acts as a project partner. In the university laboratory, opened under the “Priority-2030” program, viral vectors are being developed, which are necessary for delivering genetic material into the cell.
This element is essential for creating a product that will work inside the body and contribute to the restoration of immune tolerance, leading to remission.
Prospects
The project implementation is scheduled for 2025–2030. The technology, currently used in oncohematology, will be adapted for patients with severe rheumatoid arthritis and other systemic diseases.
“We hope that the positive implementation of the project will develop such an important element of the regional image as medical tourism, including interstate. And, of course, this extremely relevant technology will be available to our patients living in the Novosibirsk region and the Siberian Federal District.”
— Maxim Korolev, Director of NIIKEL (branch of ICG SB RAS)
