Certification of a New Batch of the Industry Reference Standard of Polysaccharide Content in Schigellvac Vaccine

Abstract

The article summarises materials on the certification of the industry reference standard of Schigella sonnei polysaccharide dysentery vaccine (commercial name — Schigellvac). The industry reference standard is used to assess the consistency of the vaccine «Specific activity» testing by passive hemagglutination inhibition assay. A certification programme for the industry reference standard was developed. Samples of the candidate vaccine were tested in terms of the following quality characteristics: «Appearance», «Identification», «Extractable Volume». The test results confirmed that the samples comply with the current requirements of the manufacturer’s product specification file for Schigellvac vaccine. It was determined that the certification parameter — the polysaccharide dilution ratio which results in inhibition of passive hemagglutination in a homologous system — has to fall in the range from 1:128 to 1:512. The following set of standard documents accompanying a scientific/technological product was approved for the industry reference standard No. 42-28-386-2017: passport, patient information leaflet, mockup labels for primary and secondary packaging.