In new drug development pipelines, there is an increasing trend to switch from “small” to “large” molecules (also known as biologics). While the FDA guidance was quite specific with their recommendations for small molecules ADME-Tox studies, there is not much currently published for these large molecules.
The Japanese PDMA guidelines 2019 issue refers to some specificity regarding their internalization and degradation pathway. They are also well known to be prone to trigger cytokine release. The so called “cytokine storm” is one of the major toxicity events to be feared.
To support R&D projects around Biologics development, I have illustrated in this post what tebu-bio can offer in terms of reagents and services, including tools to monitor cytokine release (blood derivatives and cytokine multiplex assays), and reagents to help decipher their mechanism of action and catabolism.