REVIEW OF QUALITY CONTROL APPROACHES FOR BIOTECHNOLOGY-DERIVED VACCINES

Salem Mohammed Alshahrani

Abstract: This paper aimed to systematically review the quality control approaches for biotechnology-derived vaccines, including the covid vaccines. Google Scholar was used for selecting papers, which was limited to 28 to ensure that the review is not too long. From the 28 papers, 14 were reviews. There were only four research papers, of which, two were on covid vaccines. Thus, the diversity of the available quality control approaches was already limited. Many quality control tests are performed through the entire chain of sourcing to the end-user. Safety, purity, product integrity, efficacy, immunogenicity, and absence of side effects were the important quality control variables identified as critical for the effective use of vaccines, in most studies. This observation applies to covid vaccines also. As a self-check of the quality of the vaccine by the manufacturer may not be accepted by others, it is desirable to cross-check the reliability and validity of the factory quality test results through third-party testing. Often, despite all quality parameters being satisfactory, the vaccines fail in actual use. There could be a difference between the laboratory results and the real-world experiences of covid vaccines. The factors leading to this problem are not yet clear. International guidelines and standards help to ensure uniform quality of vaccines across the world facilitating the use of the same vaccines in different countries. This is evident from the covid vaccine exports from leading producer countries to other parts of the world. The essentiality of ensuring the proper quality of all vaccines, including covid vaccines, is clear from this review. The future is for the possibility of rapid quality tests facilitated by multiplex testing tools, non-animal testing, the use of plant-based vaccines aided by molecular farming, and larger-scale field evaluations of vaccines.

Keywords: Quality control approaches, Biotechnology-derived vaccines, Systematic review

DOI: 10.24874/IJQR17.03-06

Recieved: 21.06.2022  Accepted: 06.06.2023  UDC: 005.6

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