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

As part of a strategic initiative to reconstruct and modernize the production laboratories of the St. Petersburg Research Institute of Vaccines and Serums (SPbNIIVS) of the FMBA of Russia, an expanded technical consultation was held between INEX specialists and institute representatives.

The project focuses on the modernization of technological lines dedicated to the development and production of Active Pharmaceutical Ingredients (APIs) based on recombinant proteins. These processes utilize Escherichia coli strains classified under Pathogenicity Groups III-IV, with the final substances intended for parenteral (injectable) drug production.

Project Scope: Quality Control (QC) Laboratory The QC facility is being engineered to perform rigorous testing and monitoring of:

• APIs and Intermediates: Based on capsular polysaccharides and recombinant proteins.

• Enzyme Preparations: Specifically Collalisin, derived from Pathogenic Biological Agents (PBA) of Groups III-IV.

Strategic Tasks for INEX: Following a feasibility assessment and preliminary site audit, INEX has been commissioned to execute the following critical phases:

• Comprehensive Structural Audit: A full technical assessment of the existing laboratory building.

• Detailed Engineering (Stage R): Development of working documentation for the technical re-equipment of R&D and QC blocks.

• Budgetary Documentation: Compilation of comprehensive cost estimates for the modernization.

• Design Qualification (DQ): Ensuring the engineering design meets all functional and regulatory requirements.

• Regulatory Support: Guiding the project until a positive Sanitary-Epidemiological Expert Conclusion is secured.

A cornerstone of this project is the strict adherence to the Russian Federation’s import substitution policy in the pharmaceutical sector. By utilizing its own scientific and production base, INEX ensures that the institute receives technologically independent and reliable infrastructure.

Regulatory Compliance (RF)

The engineering solutions for this federal-level facility are developed in accordance with:

• SanPiN 3.3686-21: Governing the handling of Pathogenic Biological Agents (PBA).

• EAEU GMP: Good Manufacturing Practice for sterile and biotechnological products.

• ISO 14644 (GOST R ISO 14644): Classification and monitoring of air cleanliness in critical pharmaceutical zones.

• SP 158.13330.2014: Federal design standards for medical and research institutions.