Aşı Geliştirmede Güncellemeler: Hayvan Deneylerinin Azaltılmasında İn Vitro Modellerin Rolü ve Güncel Gelişmeler

Abstract

Amaç: Aşı değerlendirme yöntemlerindeki son gelişmeleri, özellikle in vivo testlerden in vitro testlere geçişi, aşı araştırma ve kalite kontrolünde hayvan deneylerini en aza indirgemek için geliştirilen yeni teknikleri gözden geçirmek ve analiz etmektir. Gereç ve Yöntemler: Bu çalışma, aşı değerlendirme tekniklerindeki son gelişmelerin kapsamlı bir literatür taramasını gerçekleştirmiştir. Bu tarama, Avrupa Farmakopesi'ndeki değişiklikleri, hücre bazlı testleri, Modüler Bağışıklık In vitro Yapı (MIMIC) sistemini ve organoid modellerini içermektedir. İnceleme, bu yöntemlerin etkinliğini, sınırlamalarını ve potansiyel uygulamalarını değerlendirmek için hakemli makaleler, düzenleyici kılavuzlar ve endüstri raporları incelemiştir. Bulgular: Hayvan bazlı testlerin in vitro alternatiflerle değiştirilmesinde önemli ilerlemeler kaydedilmiştir. Avrupa Farmakopesi, Fare Histamin Duyarlılaştırma Testi'nin (HIST) Çin Hamsteri Yumutalığı (CHO) hücresi kümelenme testi ile ve Tavşan Pirojenite Testi'nin (RPT) Monosit Aktivasyon Testi (MAT) ile değiştirilmesi gibi değişiklikler uygulamıştır. Hücre bazlı testler, aşı geliştirmenin erken aşamalarında umut verici sonuçlar gösterirken, MIMIC sistemi insan bağışıklık tepkilerini replike etmede etkinlik göstermiştir. Organoid modeller, özellikle tonsil organoidleri, karmaşık bağışıklık etkileşimlerini simüle etmek için değerli araçlar olarak ortaya çıkmıştır.

Keywords

• hayvan deneyleri
• in vitro testler
• aşı araştırmaları

Advancing Vaccine Development: The Role of In Vitro Models and Progress in Reducing Animal Testing

Abstract

Aim: To review and analyse recent advancements in vaccine evaluation methods, focusing on the transition from in vivo to in vitro assays and the development of novel techniques to minimize animal testing in vaccine research and quality control. Materials and Methods: This study conducted a comprehensive literature review of recent developments in vaccine evaluation techniques, including modifications to the European Pharmacopoeia, cell-based assays, the Modular Immune In vitro Construct (MIMIC) system, and organoid models. The review examined articles, regulatory guidelines, and industry reports to assess the efficacy, limitations, and potential applications of these methods. Results: Significant progress has been made in replacing animal-based tests with in vitro alternatives. The European Pharmacopoeia has implemented changes such as replacing the Mouse Histamine Sensitization Test (HIST) with the Chinese Hamster Ovary (CHO) cell clustering test and the Rabbit Pyrogenicity Test (RPT) with the Monocyte Activation Test (MAT). Cell-based assays have shown promise in early vaccine development stages, while the MIMIC system has demonstrated effectiveness in replicating human immune responses. Organoid models, particularly tonsil organoids, have emerged as valuable tools for simulating complex immune interactions.

Keywords

• Animal testing
• in vitro testing
• vaccine research

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