Construction of a Prefabricated Modular Building for a Thermal Disinfection and Decontamination Station for Pathogenicity Groups III–IV Effluents

As part of the launch of the project for the reconstruction, modernization and re-equipment of production laboratories of the St. Petersburg Research Institute of Vaccines and Serums for the production of bacterial preparations, an extended working consultation of INEX specialists and representatives of research institutes was held. The modernized technological line of the enterprise is designed to develop schemes for the production and production of biologically active pharmaceutical substances (API) based on recombinant proteins, the producer of which is Escherichia coli strains (PBA III-IV groups). Substances are intended for the production of medicines for parenteral use. Quality Control Laboratory (QC) is intended for: • control of active pharmaceutical ingredients (API) of semi-finished products and finished product (FP) based on capsular polysaccharides, recombinant proteins produced by Escherichia coli strains; • enzyme preparations (Collalizin), which are produced by strains of pathogenic biological agents (hereinafter referred to as PBA) of groups III-IV. Based on the primary inspection of the laboratories and the input received, the feasibility of the project was assessed. The INEX Company has the following tasks: • Comprehensive survey of the building; • Development of working documentation for the technical re-equipment of the research laboratory and quality control laboratory; • Preparation of budget documentation; • Carrying out project qualification; • Accompaniment until obtaining a positive conclusion from the sanitary and epidemiological examination. An important requirement for the project is compliance with the import substitution policy of the Russian Federation in the pharmaceutical industry, which is provided by INEX's own research and production base.