Today, national healthcare is in need of effective domestic influenza and ARI remedies. Research Institute of Influenza is one of the few medical centres in Russia capable of designing, manufacturing and conducting full–scale trials of novel antiviral medications. The ability to manufacture antivirals directly at the RII allows for quick and efficient integration of research breakthroughs into medical practice. Currently, RII runs its own diagnostic reagent production facility and trial facilities for manufacturing vaccines and pharmaceuticals, with firm plans of establishing full scale commercial production in the future, which will allow the Institute to gain additional funding for its scientific activities.
Diagnostic Reagent Production
RII manufactures a variety of modern diagnostic kits and reagents for use in domestic healthcare and national influenza surveillance. The core unit behind the production is Laboratory of Biotechnology of Diagnostic Reagents. Laboratory specialists apply the most up-to-date techniques of virus collection, purification and concentration, Immunoblotting, Immunochromatographic Assay, ELISA, IFA, hybridoma technology and ensure that proper quality and safety standards are met. The list of developed and authorized diagnostic reagents includes fluorescent immunoglobulins and ELISA systems, serological reagents and monoclonal antibody panels to primary agents of influenza and ARI, which will substitute polyclonal immunoglobulins in the production process. Domestic production of necessary diagnostic reagents by RII allowed for establishing efficient national influenza and ARI surveillance system, which is able to recognize emerging epidemics in Russia, and analyze their development and etiology. RII diagnostic kits were used to detect a primary outbreak of pandemic influenza A/H1N1 virus during May–June, 2009, in Moscow, and its’ further spread across the country.
RII vaccine manufacturing facility was designed and constructed by MFarm in accordance with GOST national standards. The facility allows state-of-the-art molecular and biological techniques for vaccine development. Vaccines are produced with the help of Vero cell-culture based manufacturing technology, using the strain compositions recommended by WHO.
RII operates a trial facility for small scale drug manufacturing. The facility was designed jointly by the Russian firm «Pharmster» and Czech «Lab&Pharma». The project includes areas for producing protein and peptide–based injectable antivirals and active substances, and alternative drug forms (sprays, ointments, suppositories). Currently, the facility allows limited drug manufacturing for clinical investigation purposes. The plans are to establish full scale medicine fabrication in the near future for research and commercial uses. The future products will include Interferon–Gamma (IFN-γ) and Interferon–Alpha (IFN-α), which possess antiviral, immunoregulatory, and anti-tumor properties, and other cytokines.
The facility is managed by the Laboratory of Medicine Technology. At the lab, scientists are working on novel drug designs and their production techniques. The lab is equipped with aerosol chamber, tablet press, gel cap filling machine, suppository production machine, Waters high–pressure chromatograph and control instrumentation.
Division of Biological and Technological Control ensures all the necessary quality and safety standards are met during the manufacturing process. The Division conducts physical and chemical analyses, biological assays, sample storage and keeps production records.