抽象的な

Quality control of vaccines-A journey from classical approach to 3Rs.

Suresh K, Mahendra PS, Vijay KB, Ramendra PP

Most vaccines for human and veterinary use are complex biological preparations having one or more antigens along with an adjuvant product to improve the immune response against the specific disease. Conventional vaccines have used numerous animals for production and quality compliance before the release of the final product. Animal based potency tests were required to help in ensuring that each batch of vaccine is consistently safe, pure, potent and effective by providing a level of protection as determined in the original efficacy studies. As a result, the levels of pain and suffering in animals were compromised as compared to other purposes of animal experimentation. Therefore, there is a need to identify viable options to replace these methods of vaccine production and quality check without affecting their quality, potency, and efficacy. This review article will highlight the progress and breakthroughs about the achievements of 3Rs (replace, reduce, and refine) principles especially in the development of alternative test models including physio-biochemical, immunochemical and in-vitro methods using so- called “consistency approach” in the area of human and veterinary vaccinology. This article also provides a critical review on the various methods used for potency assays and the factors affecting the accuracy of these methods.