A replacement approach to rodent model for the toxicity evaluation of gram-positive autogenous vaccine.

The Abnormal Toxicity Test (ATT) is an in vivo assay traditionally used in the autogenous vaccine release. That test, commonly applied to verify vaccine quality, is subject to ethical and practical limitations and should be removed as reference methods. This approach is necessary to update the regulatory framework and to apply the 3Rs principle in the pharmaceutical field.

Hep3Gel: A Shape-Shifting Extracellular Matrix-Based, Three-Dimensional Liver Model Adaptable to Different Culture Systems.

Drug-induced hepatotoxicity is a leading cause of clinical trial withdrawal. Therefore, in vitro modeling the hepatic behavior and functionalities is not only crucial to better understand physiological and pathological processes but also to support drug development with reliable high-throughput platforms. Different physiological and pathological models are currently under development and are commonly implemented both within platforms for standard 2D cultures and within tailor-made chambers.