{"title":"Mini review on Potency Evaluation of Rabies Vaccine preparations","authors":"walaa Rashed, Khaled Aboshanab, M. Aboulwafa","doi":"10.21608/aps.2021.101125.1071","DOIUrl":null,"url":null,"abstract":"Rabies is still considered one of the most harmful viral infections of warm-blooded animals. Thousands of people are infected with it each year worldwide. It is a fatal disease unless early treatment is received before the appearance of symptoms. The virus usually enters the human body through a bite wound from rabid animal’s saliva; however, it can also be transmitted by other ways such as inhalation of the aerosolized rabies virus with laboratory workers. About, twenty-four thousand die due to rabies in Africa annually and dogs are the main reason for infection transmission. Fortunately, it is easily eliminated by vaccines. The importance of vaccination comes from the fact that it is the only way to limit disease mortality levels; meanwhile, the same vaccine is used for treatment after infection exposure to rabies or as prophylaxis. Therefore, high-quality control must be applied to it to ensure its safety, efficacy, and potency. A potency test is an important tool for experiencing the actual relative potency of manufactured vaccine batches. Because of the high variability of biological products, potency is an effective tool that assures the lot-to-lot consistency of commercial vaccines. In this review, we aimed to discuss the rabies virus and its antigenic structure, different vaccine preparations, quality control of vaccines, different methods used in potency tests for rabies vaccine preparations including in vivo and in vitro methods. In conclusion, without good quality control, we couldn’t ensure consistency in vaccine manufacturing, and without replacement of old methods depending on animals, we couldn’t go with global approaches of refinement, reduction, and replacement of animals in quality control tests especially the potency test.","PeriodicalId":8314,"journal":{"name":"Archives of Pharmaceutical Sciences Ain Shams University","volume":null,"pages":null},"PeriodicalIF":0.0000,"publicationDate":"2021-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Archives of Pharmaceutical Sciences Ain Shams University","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.21608/aps.2021.101125.1071","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 0
Abstract
Rabies is still considered one of the most harmful viral infections of warm-blooded animals. Thousands of people are infected with it each year worldwide. It is a fatal disease unless early treatment is received before the appearance of symptoms. The virus usually enters the human body through a bite wound from rabid animal’s saliva; however, it can also be transmitted by other ways such as inhalation of the aerosolized rabies virus with laboratory workers. About, twenty-four thousand die due to rabies in Africa annually and dogs are the main reason for infection transmission. Fortunately, it is easily eliminated by vaccines. The importance of vaccination comes from the fact that it is the only way to limit disease mortality levels; meanwhile, the same vaccine is used for treatment after infection exposure to rabies or as prophylaxis. Therefore, high-quality control must be applied to it to ensure its safety, efficacy, and potency. A potency test is an important tool for experiencing the actual relative potency of manufactured vaccine batches. Because of the high variability of biological products, potency is an effective tool that assures the lot-to-lot consistency of commercial vaccines. In this review, we aimed to discuss the rabies virus and its antigenic structure, different vaccine preparations, quality control of vaccines, different methods used in potency tests for rabies vaccine preparations including in vivo and in vitro methods. In conclusion, without good quality control, we couldn’t ensure consistency in vaccine manufacturing, and without replacement of old methods depending on animals, we couldn’t go with global approaches of refinement, reduction, and replacement of animals in quality control tests especially the potency test.