ISSUE 44 — The Importance of Cytokine Release Assays to Derisk the Development of Immunomodulatory Drugs
New immunomodulatory drugs have the potential to cause serious immune-related adverse events, including cytokine release syndrome (CRS). CRS is a systemic inflammatory response characterized by the release of
In Issue 44 of The Altascientist, we review strategies, including those implemented at Altasciences, for developing, qualifying, and implementing cytokine release assays (CRAs) to assess the safety of test articles in vitro to complement in vivo preclinical safety assessments, in addition to:
- the importance of nonclinical cytokine release evaluation
- customized approaches to CRA use in drug development
- top five aspects to consider before running a CRA
- Altasciences’ case results
- how Altasciences can help
Drugs that are likely to require CRAs as part of derisking their development include, but are not limited to:
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