Biotechnologia Acta

25-38

Authors: O. Yu. Galkin, A. G. Komar, M. O. Pys’menna

The aim of this research was to analyze recent scientific literature, as well as national and international legislature on manifacturing process validation of biopharmaceutical production, in particular devices for serological diagnostics. Technology validation in the field of medical devices for serological diagnostics is most influenced by the Technical Regulation for Medical Devices for in vitro Diagnostics State Standards of Ukraine – SSU EN ISO 13485:2015 “Medical devices. Quality management system. Requirements for regulation”, SSU EN ISO 14971:2015 “Medical devices. Instructions for risk management”, Instruction ST-N of the Ministry of Healthcare of Ukraine 42-4.0:2014 “Medications. Suitable industrial practice”, State Pharmacopoeia of Ukraine and Instruction ICH Q9 on risk management. Current recommendations for validations of drugs manufacturing process, including biotechnological manufacturing, can not be directly applied to medical devices for in vitro diagnostics. It was shown that the specifics of application and raw materials require individual validation parameters and process validations for serological diagnostics devices. Critical parameters to consider in validation plans were provided for every typical stage of production of in vitro diagnostics devices on the example of immunoassay kits, such as obtaining protein antigens, including recombinant ones, preparations of mono- and polyclonal antibodies, immunoenzyme conjugates and immunosorbents, chemical reagents etc. The bottlenecks of technologies for in vitro diagnostics devices were analyzed from the bioethical and biosafety points of view.

58-63

Authors: Yu. P. Rud, M. I. Maistrenko, L. P. Buchatskiy

The aim of the research was to investigate diseased fish species Labeo (Labeo bicolor) and Sack-gill Catfish (Heteropneustes fossilis) by testing several diagnostic systems targeting fish herpesviruses in purpose to determine the etiology of the outbreak infection in aquarium fishes at the Kуiv Zoo during summer 2017. During a fish health inspection of aquariums in Kyiv Zoo, an Cyprinid herpesvirus 3 − CyHV-3 was detected in Labeo and Sack-gill Catfish. Preliminary examination of infected fish revealed a range of lesions particularly in internal organs and tissues. The gills of diseased fish were characterized by hyperaemia and necrosis. The infringement of liver color and structure, kidney swelling and gallbladder necrosis were observed in both fish species. The virus did not grow in fish cell lines of RTG-2, FHM and EPC, that was evident by absence of any morphological changes in appropriate cell lines. Also initially fish were tested for parasitic and bacterial infections and they were determined to be non-infected. Our results demonstrated that specific oligonucleotide primers for thymidine kinase gene of CyHV-3 were successfully amplified the specific DNA fragments. The length of polymerase chain reaction product, as expected, was 264 nucleotide pairs. The amplified specific fragments were identical to the area of thymidine kinase gene CyHV-3, as was shown by sequence analysis. The identity of nucleotide sequences composed 97‒99%. The same positive results were obtained using primers that recommended by the International Epizootic Bureau, fragments in size of 409 and 292 were also obtained. In our opinion, CyHV-3 was brought to Ukraine by import of aquarium fish avoiding sanitary control of transboundary transportation. Therefore, the uncontrolled import of aquarium and cultured fish species is a serious problem because imported fish could be as a source of highly pathogenic infections for industrial aquaculture.

70-75

Authors: T. Y. Trokhymchuk, L. A. Ganova, N. Ya. Spivak

The purpose of the work was to study the ability of test systems DIA-HIV ½ and DIA-HIV-Ag/Ab produced by PJSC “SPC “Diaproph-Med” to detect HIV infection. Reference blood serum of HIV-positive patients was tested using immunoassay analysis. It was shown that early detection of HIV infection is more effective using test kits of the fourth generation, which should be used for primary screening for HIV, and third-generation test systems should be used to confirm the positive results of primary analysis.