In December 2013, the Slovak pharmaceutical company IMUNA PHARM, a.s., based in Šarišské Michaľany, launched a new applied research project in the field of human vaccines using innovative technological procedures, with the aim of ensuring the independence of the Eastern European region in the production of vaccines using new technological procedures.
The project entitled "Research of innovative treatment procedures and technological procedures for the production of a combined vaccine and the establishment of a seed lot system" is implemented with the financial support of the Ministry of Education, Science, Research and Sport of the Slovak Republic, based on the Agreement on the provision of incentives for research and development, no. 0782/2013, concluded in accordance with the Decision of the Ministry of Education, Science, Research and Sport of the Slovak Republic no. 2013-14549/39695:1-11. The first step to ensure the implementation of the project was the creation of three new jobs for sales and research workers at the current research and development workplace of the company and their filling by experts in this field. As part of the project, three new jobs were created for highly qualified research and development workers. During 2014, the gene map of the rubella strain was developed and compared. At the same time, the conditions for cultivation of the rubella strain in semi-operational conditions were defined. The conditions for the semi-operational production of a monovaccine against measles and against mumps after the implementation of the developed innovative technological procedure of multiplication of viruses on chicken fibroblasts were selected.
In 2015, the preparation of maternal and working banks for the mumps and measles virus propagated on chicken embryonic fibroblasts, as well as pilot banks for the cell line of diploid cells, was carried out. The first activities related to the preparation of the mother bank for the pharmaceutical cell substrate supplied from the WHO-recommended source have been initiated and are currently ongoing. A scale-up of optimized technological procedures for multiplying the rubella virus on diploid cells to the required production volumes of the vaccine batch was implemented, as well as for the purpose of preparing the mother and working bank for the rubella virus strain. These pilot banks of viruses and cells were tested for initial critical parameters. All the results of these tests were satisfactory.
In 2016, in accordance with the planned goals of the solved project, the production process of the liquid monovaccine against rubella was optimized and the selection of a suitable stabilizer. In addition to the liquid monovaccine against rubella, 10 batches of lyophilized monovaccine against rubella as well as 4 batches of the combined vaccine against MMR with various stabilizers were prepared. The first preclinical tests on animals were carried out, the results of which were satisfactory for all tested lots. Furthermore, two new methodologies were optimized and introduced for testing prepared vaccines (lyophilized and liquid form) for the presence of Mycoplasma spp. and Lovibond colorimetric test.
Implementation of this project in IMUNA PHARM, a.s. it is fully in line with the government's program to increase the number of jobs in key regions with a high unemployment rate, such as eastern Slovakia, to prevent the leakage of expert scientific personnel abroad and to ensure the independence of the Eastern European region in the production of vaccines.
Source: IMUNA PHARM, a.s.