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3Rs expression in quality control paradigms of human vaccines 


Pharmacy & Pharmacology International Journal
SyedaShazia Adeel,1 Tanveer Ahmed Khan,1 Kanwal Batool,1 Baseer Ahmad Khan2

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Abstract

Communicable diseases remain the leading cause of mortality worldwide in past. Children and adolescent were the most affected individuals. However, the development of vaccine played a vital role in decreasing mortality and increasing life expectancy. Currently most of vaccines are based on utilizing animal pathogens and use of animals. This use of animal in quality testing of vaccines is inevitable. Over the past century, concern about animals’ interests was limited to ensure that animals be treated humanely and not subjected to unnecessary sacrifice and sufferings. However, with the rise of 3Rs concept the global scenario for use of animals is being changed a little. The current review addresses the refinement, reduction and replacement aspects of animal use in vaccine testing. It also dialogues about challenges to implement 3Rs and gadget this key concept for effective quality testing.The acceptability and implementation of 3Rs concept is based on good manufacturing practices, good in-process quality control and validated procedures and processes. It is easier for new vaccines to adopt this concept. However, several difficulties are still experienced in theimplementation of 3Rs principles for vaccine potency assays. Thus, insistent exploration is obligatory by bothhealth industries and regulatory agencies for the implementation and validation of robust 3Rs approaches around the globe.

Keywords

vaccination, quality control, 3Rs, potency testing

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