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

In October 2022, following high-level negotiations between StroyBioLab LLC and INEX, an agreement was signed for the development of detailed engineering ("Stage R") and cost-estimation documentation. The project focuses on the technical re-equipment of the Research Laboratory and Quality Control (QC) Laboratory located within Laboratory Building Lit. A at the St. Petersburg Research Institute of Vaccines and Serums (SPbNIIVS) of the FMBA of Russia.

Located in Krasnoye Selo (52 Svobody St.), SPbNIIVS is Russia’s oldest scientific and manufacturing institution in its field, with a history dating back to 1886. To date, the institute has developed and implemented over 200 types of immunobiological preparations.

[Image: Architectural rendering of the modernized laboratory complex for vaccine research]

Current Priorities of SPbNIIVS:

• Prophylactic Vaccines: Large-scale development and production of vaccines against influenza, hepatitis, tuberculosis, and other infectious diseases.

• Therapeutic Agents: Manufacturing of anti-cancer treatments, antiseptics, and dermatological medications.

• Diagnostics: Production of diagnostic tools for tuberculosis, enteric and coccal infections, and blood group identification.

The strategic objective of SPbNIIVS FMBA Russia is to secure a leading position in the markets of the Russian Federation and internationally. INEX is proud to contribute to the modernization of the research and production infrastructure of such a historically significant and high-tech enterprise. Work on the project has successfully commenced.

[Image: Engineering team conducting initial site measurements in the laboratory building]

Regulatory Compliance (RF)

The documentation and subsequent technical upgrades are engineered in accordance with the following standards:

• EAEU GMP & GLP: Ensuring that production and laboratory environments meet international quality and safety benchmarks.

• Decree of the Government of the Russian Federation No. 87: Governing the strict requirements for the composition of project documentation.

• SanPiN 3.3686-21: Regarding the prevention of infectious diseases and biological safety protocols for laboratory facilities.

• ISO 14644 (GOST R ISO 14644): Cleanroom standards for maintaining controlled environments in vaccine R&D.