TehLAB introduced a biostatistical ParCur analysis system in NatiVita

2020: Implementation of biostatistical analysis system

TEKHLAB"" December 21, 2020 announced the introduction of a system of biostatistical analysis as part of the transfer of the Russian pharmaceutical production technologies in a company - NatiVita a representative oncological in the segment of the Republic. Belarus

The organization of technology transfer in the pharmaceutical market requires taking into account not only Russian, but also international regulatory requirements in the development, production and circulation of medicines. One of the quality assurance processes of the European Pharmacopoeia and the United States Pharmacopoeia Convention (quality control standards valid in all States Parties to the Convention) is the statistical analysis of the characteristics of the products produced.

Such a process did not become an innovation in the framework of product quality control procedures in the technology transfer project for the group of drugs of the oncological segment of BIOCAD and NatiVita companies, but naturally required the implementation of a uniform approach. To achieve this goal, an IT solution was chosen ParCur - an electronic system of statistical analysis of data using parallel curves that meets the requirements of the conventions. It significantly reduces the labor cost of conducting statistical data analysis and processing the results of experiments to evaluate the specific activity of monoclonal antibodies. ParCur allows you to import data from specialized software of laboratory microplate readers. The downloaded data is analyzed in separate configurable, template or user-cloned multiparameter experiments, allowing you to reduce the time to prepare a new experiment and take into account all the details of its conduct. The result of the work of the embedded system is a report including a conclusion on the suitability of the data, the reliability of the results according to the selected evaluation parameters and the total value of the activity of monoclonal antibodies. The system interface is ParCur localized in English to ensure the work of specialists in any foreign branches of customer companies.

The author of the transferred technologies as part of the transfer project was Biotechnology company BIOCAD, a company that combined a research center, biotechnology production, preclinical and international clinical research that meets modern standards.

As of December 2020, the NatiVita testing laboratory is evaluating the specific activity of drugs based on monoclonal antibodies using developed technology.

TehLAB specialists modernized the analytics and reporting module of the ParCur system, taking into account the peculiarities of the project and implemented its implementation. They also participated in the training of customer specialists on the use of the system and provided assistance in the validation procedure of the new version of the system at the enterprise. The implementation of the project implied the installation of a fully autonomous version of the ParCur in the data center at the Belarusian production of NatiVita. This made it possible to ensure the availability and security of data storage about the test results.

Thanks to the introduction of ParCur, we were able to automate a large amount of routine operations related to the analysis of statistical data and the processing of experimental results. As a result, the work of laboratory specialists on these processes has been significantly reduced, and they may pay more attention to checking the reports received. The new IT solution meets the needs of the pharmaceutical business, which seeks to minimize manual labor and prevent errors that may arise due to the human factor, "comments Alexander Karavaev, deputy general director for information technology and information security at SOOO NATIVITA.