Биопрепараты: Профилактика, диагностика, лечение (Feb 2018)
Certification of the industry reference standard for the specific activity of «BiVac polio» - live attenuated bivalent oral polio vaccine type 1 and 3
Abstract
The standardization and control of «BiVac polio» (live attenuated bivalent oral polio vaccine type 1 and 3) developed by M. P. Chumakov Institute of Poliomyelitis and Viral Encephalitides of the Russian Academy of Medical Sciences, called for establishment of an industry reference standard (IRS) to be used in determination of infectious units for each type of the poliovirus in a vaccine dose, according to the requirements of the quality standard. The article gives an account of certification performed for the first batch of a live attenuated bivalent oral polio vaccine type 1 and 3 IRS. The following parameters were tested: Clarity, Colourity, рН, Sterility, Identification, Specific activity, Thermal stability. Identification, Specific activity and Thermal stability of the candidate reference standard were assessed in comparison with the vaccine poliovirus type 1 IRS (IRS 42-28-362-2016) and vaccine poliovirus type 3 IRS (IRS 42-28-372-2015). The IRS certified parameter was found to be: 107.38±0.38 TCID50/ml for type 1 and 106.7±0.48 TCID50/ml for type 3. The IRS was assigned with the number IRS 42-28-434-2016 and a shelf life of 1.5 years. The IRS can be used in specific activity testing of «BiVac polio» commercial batches.
