Introducing Philippine-Origin Cynomolgus Macaque (Macaca Fascicularis Philippensis) As A Research Model In Drug Safety Assessment

By Yafei Chen, Tara Arndt, Anthony Celori, Johanna Rigas, Pierre Jolicoeur, Norbert Makori, George De Los Santos and Wendell P. Davis

Supply shortages and rising demand for cynomolgus macaques (Macaca fascicularis) in (bio)therapeutic drug development have led to increased reliance on animals sourced from various geographical regions. This shift has raised concerns about potential genetic and environmental variability that could impact the interpretation of nonclinical toxicity study results.

A recent special issue of Toxicologic Pathology explored these concerns, highlighting the complexities introduced by using cynomolgus macaques from different origins. The key findings from this issue support the inclusion of animals from diverse regions—including Cambodia, China, Vietnam, Indonesia, and Mauritius—within drug development programs. However, they emphasize the importance of maintaining scientific rigor by ensuring robust justifications, establishing reliable reference data, and preserving consistency in animal origin within each study to minimize variability and enhance data reliability.