The Cell Technology Center was established at the Institute of Cytology of the Russian Academy of Sciences in Saint Petersburg. It is one of the first Russian laboratories which will act in accordance with the new Law «On Biomedical Cell Products». The Cell Technology Center of the Institute of Cytology of the Russian Academy of Sciences will enhance development, standardization, manufacturing and practical implementation of emerging cell products in accordance with Russian and international rules and regulations.
The Cell Technology Center of the Institute of Cytology of the Russian Academy of Sciences was inaugurated by (from left to right): Vsevolod Arsenievich Tkachuk, Dean of the Fundamental Medicine Faculty in Lomonosov Moscow State University, President of National Society for Regenerative Medicine; Natalia Arkadievna Mikhailova, acting Director of the Institute of Cytology of the Russian Academy of Sciences; Nikolai Nikolaevich Nikolsky, member of the Russian Academy of Sciences
The Center is based on advanced equipment in «clean room» of the special laboratory, which is designed and constructed by the Institute in accordance with GMP requirements. Here, Sartorius CompacT automated cell culture system was installed by OPTEC Group specialists. This robotic system offers the possibility of live cell culture under full control in accordance with set protocols without human intervention, 24 hours a day.
Natalia Mikhailova, acting Director of the Institute of Cytology of the Russian Academy of Sciences, said: «We have constructed the Center for two years. From the very outset, strict requirements were imposed on technology level and lab design in order to achieve full compliance with accepted international standards in the field of cell technologies. It made us one of the first Russian research centers which are ready to work under the new biomedical cell product legislation».
The Institute of Cytology of the Russian Academy of Sciences makes researches in the field of cell biology and creates new cell technologies for over 30 years. It is one of leading institutes of the Russian Academy of Sciences in this field. The laboratories of the Institute have developed cell product series which includes a dermal equivalent for treatment of various skin lesions including chronic incurable diseases as well as supercritical and critical burns. This dermal equivalent saved the lives of several burn patients.
«The dermal equivalent or „artificial skin“ is a known product of the Institute of Cytology, which was used and appreciated in clinical practice. The Institute was licensed to use it for five years, but couldn’t extend the license due to lack of legislation. The Cell Technology Center will prepare the dermal equivalent for clinical use in accordance with the new law and GMP requirements in order to offer this needed product to health facilities again», Natalia Mikhailova said.
Another field of work is performing in vitro nonclinical studies of pharmaceutical drugs and medicines for human use in cell cultures. This practice becomes world standard because it allows minimizing useof laboratory animals and making study more accurate, cost-effective, fast and extensive. New cell culture system will allow collecting data required by application and research tasks in this field in accordance with international GMP requirements.
Capabilities of new CompacT cell culture system will be used to create stem cell banks for future studies in accordance with GMP requirements. «We negotiate with international partners about creationof the international stem cell bank (haplobank) with active participation of the Institute of Cytology of the Russian Academy of Sciences in this project. This concept is based on the possibility of reprogramming healthy donor’s mature cells into immature stem cells (iPSC, induced pluripotent stem cells). Later, they can be turned into any specialized cells and tissues and used in transplantation for patients, for nonclinical studies, and in many other medicine and biology areas. International sharing is necessary because the international bank will provide all the participants with required biocompatible material. This attractive project can evolve in tandem with the new Cell Technology Center», Natalia Mikhailova said.
The Cell Technology Center of the Institute of Cytology of the Russian Academy of Sciences in collaboration with Sartorius Stedim Biotech and OPTEC (manufacturer and supplier of CompacT automated cell culture system) will create Russian-Scandinavian reference center of cell technologies. The Center will focus on setting and development of cooperation between Russian and European scientists, development, testing, certification, and implementation of new techniques in the field of cell technology, sharing of experience, support of education, and advanced professional training of experts (scientists and healthcare professionals) in the field of cell biology.
Agreement for creation of Russian-Scandinavian reference center of cell technologies was signed by (from left to right): Irina Volkova, CEO of Sartorius Stedim RUS, Natalia Mikhailova, acting Director of the Institute of Cytology of the Russian Academy of Sciences, Olga Seredkina, CEO of OPTEC Russia
The Institute of Cytology of the Russian Academy of Sciences implements a scientific program involving development of organization in order to perform world-class research and development, manufacturing of high-technology products within the framework of grant the Russian Scientific Foundation (RSF) project No. 14-50-00068. The Cell Technology Centerwas created on the base of the Institute of Cytology of the Russian Academy of Sciences within the framework of grant RSF project, with the financial support from the Federal Agency for Scientific Organizations of Russia.
