In July 2020, as part of the state assignment of the Russian Health Ministry “Development of allogeneic tumor-specific T cells with an anti-CD19 chimeric antigen receptor” (supervised by Director of the Institute of Oncology and Hematology Professor Andrey Zaritskey and Head of Department of Fundamental Oncology with Genetic Engineering and Cell Therapy Group Alexei Petukhov) Almazov Centre opened the new laboratory of genetic engineering and cell therapy.
The laboratory is located in the Preclinical Translational Research Centre and is divided into four units related by a common process: analytical assays, vector production, cell processing, cryopreservation and storage.
The laboratory has the facilities to develop and scale up the production of adeno-associated viral vectors and lentiviral vectors of chromatographic purity, which are further directly used both for gene or cell therapy and for the development of vaccines, including against viral infections.
Experimental production and purification of DNA preparations, adeno-associated and lentiviral vectors is currently underway. The laboratory is capable of producing up to 40 liters of culture containing the target product in one cycle.
As part of an experimental research, based on selected candidate vectors, by the end of 2021 it is planned to manufacture batches of an allogeneic CAR-T drug for preclinical trials of therapy for lymphoproliferative diseases.
By the end of this year, the scientists intend to scale up the production of adeno-associated vectors.
The laboratory has clean rooms with bioreactors and the necessary analytical equipment; scalable technologies and products can be transferred to the production sites of biotechnological companies.
The laboratory is also working on obtaining unique animal models of lymphoproliferative disorders in cooperation with research organizations in France and Russia.
The results of the studies were summarized in early 2020 in the publication:
E.K. Zaikova, K.A. Levchuk, D.Yu. Pozdnyakov, A.A. Daks, A.Yu. Zaritskey, A.V. Petukhov Effective transduction of T cells with lentiviral particles in onco-immunology studies // Clinical Onco-Hematology, 2020; 13 (3): 295-306.