Stability Study of Measles AIK-C Strain, Mumps RS-12 Strain and Rubella Takahashi Strain in MMR Vaccine

Document Type: Original Articles

Author

Department of Bio bank, Quality Control Management, Razi Vaccine and Serum Research Institute, Karaj, Iran

Abstract

Stability studies play a critical role in assuring product quality at all points in the vaccine life cycle and have
a major impact on the success of immunization programs worldwide. The purpose of stability study is
determination of the vaccine quality under the variety of environmental factors and to establish a re-test
period or a shelf life and recommended storage conditions. In this study three batches of MMR vaccine of
Razi institute in Iran with AIK-C strain for measles, RS-12 strain for mumps and Takahashi strain for
rubella were tested for accelerated stability, after seven days incubation at 37 °C and for long-term stability
the samples were stored at 2-8 °C and tested intervals in three months until 36 months after production. All
of quantitative and qualitative control tests including Potency and Identity, Safety, Sterility, Mycoplasma
and Physicochemical tests were done in each period. In accelerated stability the mean loss of activity was
0.375, 0.373 and 0.210 log10 and in long-term stability the mean loss of activity was 0.626, 0.50 and 0.46
log10 for measles, mumps and rubella components of MMR vaccine respectively. In residual moisture test
the mean increase of moisture content in the vaccines was 1.084 %.In qualitative tests the vaccine met the
WHO specifications too. Results of this research indicated the MMR vaccines with these strains are stable
at least 36 months if the cold chain considered properly.

Keywords

Main Subjects


Article Title [French]

Etude de stabilité des souches AIK-C de la rougeole, RS-12 des oreillons et Takahashi de la rubéole dans un vaccin RRO.

Abstract [French]

Les études de stabilité jouent un rôle important dans le suivi de la qualité du produit tout au long de son cycle de vie et impactent directement le succès des programmes de vaccination à travers le monde. L’objectif d’une étude de stabilité est de déterminer la qualité du vaccin sous l’influence de facteurs environnementaux variés et de définir une période de péremption ainsi que des conditions de conservations appropriées. Dans cette étude, trois lots de vaccin RRO de l’Institut Razi d’Iran composés des souches AIK-C de la rougeole, RS-12 des oreillons et Takahashi de la rubéole ont été soumis à un test accéléré de stabilité de 7 jours à 37°C et de stabilité à long terme sur une période de 36 mois pour des vaccins conservés à 2-8 °C (analysés tous les 3 mois après production). Une batterie complète de contrôles qualitatifs et quantitatifs comprenant des analyses d’activité, d’identité, d’innocuité, de stérilité, de contamination mycoplasmique ainsi que des tests physicochimiques a été effectuée à chaque période. La perte moyenne d’activité pour chacune des souches AIK-C de la rougeole, RS-12 des oreillons et Takahashi de la rubéole était respectivement de 0,375, 0,373 et 0,210 sur une échelle de log10 lors du test accéléré de stabilité et de 0,626, 0,50 et 0,46 log10 dans le test de stabilité à long-terme. Le test de mesure de l’humidité résiduelle montrait une augmentation moyenne de 1,084% de la teneur en humidité des vaccins analysés. En conclusion, les résultats des analyses qualitatives des trois souches du vaccin RRO étaient conformes aux exigences de l’OMS et montraient une stabilité d’au minimum 36 mois, si la chaîne du froid est respectée.

Keywords [French]

  • RRO
  • Etude de stabilité
  • Vaccin
  • Contrôle de l’activité
  • Contrôle de qualité
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