Comprehensive guide on ICH Q1A(R2) storage conditions, testing intervals, stability data for IND/NDA submission, and ...

ICH stability chambers with continuous monitoring for long-term, intermediate, and accelerated studies supporting FDA ...

Stability studies are essential for assessing a biotherapeutic’s sensitivity to factors that cause aggregation and ultimately degradation of the biologic. This can impact the biologic’s activity, ...

Vaccines have been proven to be efficacious in controlling the spread of coronavirus disease 2019 (COVID-19). Among the different kinds of vaccines available, mRNA vaccines became the frontrunners in ...

In a new study published in the Proceedings of the National Academy of Sciences, authors Gabriel Gellner and Kevin McCann from the University of Guelph and SFI External Professor Alan Hastings (UC ...