Nanolek is set to establish a new research and development (R& D) center focused on transferring and advancing the technology for the production of domestic vaccines, including those against the human papillomavirus (HPV), shingles, and other infections. Nanolek aims to handle the full cycle of drug creation — from the active pharmaceutical ingredients to the final dosage forms. The center will be created within the company’s biotechnological complex in the Kirov region.
Nanolek will open a research and development center for pharmaceutical development as part of its investment program, aimed at creating new capacities for the production of biotechnological substances and full-cycle vaccines to combat socially significant diseases, including those against human papillomavirus and shingles. The new R& D center will build on the legacy of the company’s Early Development Center, which was previously located in the Pushchino science town near Moscow. One of the primary objectives of the Center’s team will be to develop vaccines starting from the active ingredient stage through to preclinical and clinical trials, and then scaling up to production. The proximity of the R& D Center to Nanolek’s biomedical complex is crucial for facilitating the transfer of production technologies to an industrial scale.
It’s worth noting that Nanolek plans to invest 5 billion rubles to expand production capacities and add new lines at the plant for producing the HPV vaccine and other pharmaceuticals. Close cooperation between the scientists at the R& D center and the production team will be mutually beneficial. Biotechnologists will gain insight into the capacities needed to scale up drug production from the earliest stages of development, while production specialists will be able to take the scientists' input into account when creating and upgrading production lines.
Nanolek has tasked the biotechnologists of the R& D center with transferring the first domestic HPV vaccine to the production facilities of the biotechnological complex. It is important to note that this vaccine is currently undergoing Phase III clinical trials in children and adolescents. In addition, Nanolek scientists are actively working on the genetic design, cultivation processes, isolation, and purification of antigens for a shingles prevention vaccine. The start of preclinical studies for this vaccine is scheduled for early 2025.
The scientific and practical center will occupy an area of 300 square meters and will be equipped with all necessary equipment for the development and production of vaccine batches for preclinical and clinical studies, including advanced laboratory facilities. Immediate plans include obtaining a license for activities involving the use of infectious agents from the III-IV groups of pathogenicity. This will allow to work with attenuated strains of pathogens, which are incapable of causing infection, as well as with model platforms such as E. coli or yeast cells for the development of recombinant antigens. The safety of the production facility and its personnel will be ensured. The vaccines produced will comply with domestic and international standards for efficacy and safety. Although the recombinant vaccines developed at the center cannot cause infection, they will enable the human immune system to develop antibodies, establish a memory of the antigen, and effectively protect the body from disease when confronted with a real infection.
With the establishment of the Center for Pharmaceutical Development in the Kirov region, Nanolek is strengthening its cooperation with another key regional institution, Vyatka State University. Vyatka State University has one of the country’s largest educational and scientific-applied bases, equipped with modern analytical laboratories. This infrastructure not only trains high-level specialists but also supports all necessary research activities. Traditionally, the Nanolek biomedical complex has served as a practical training and internship site for university students. Now, these future scientists will have the opportunity to acquire specialized skills at the Research and Development Center and potentially pursue careers there. As a result, Vyatka State University will play a direct role in the development of domestic vaccines.
Vladimir Nesterenko, CEO of Nanolek, states: “Developing our own technology for producing active pharmaceutical ingredients is a strategic priority for us. Achieving this goal will enable us to manufacture vaccines in Russia on a full-cycle basis. Establishing our own research and development center is an important step in this direction. Nanolek has the necessary expertise in this area. The new division will draw on the experience of our early development center in Pushchino, but it will focus not only on scientific but also on practical applications. This is why we are locating the center close to our production site. It will be integrated into the plant’s pharmaceutical safety system, and its employees will have the opportunity to scale up technologies developed on-site. We are planning to allocate about half a billion rubles to equip the center. Our current focus is on HPV and shingles vaccines. By 2030, we aim to develop five additional vaccines. All our efforts are aimed at enhancing vaccine accessibility for the people of our country and ultimately protecting public health, which aligns with Nanolek’s mission.”