Clinical Pathology Reference Data For The Philippine Cynomolgus Monkey For Preclinical Toxicology Studies

By Johanna Rigas, Antoni Celori, Tara Arndt, Wendell P. Davis, Yafei. Chen, and Sierra Rooks

The demand for cynomolgus macaques (CM; Macaca fascicularis) in biotherapeutic development has significantly increased due to various global factors, including the SARS-CoV-2 pandemic and exportation challenges. This heightened demand has led to the exploration of underutilized CM origins in preclinical toxicology programs. However, genetic and environmental variability among CM origins can complicate data interpretation, highlighting the need for robust reference data to accurately assess test article-related effects.

This study focuses on Philippine-origin cynomolgus macaques, an origin that is not commonly used compared to Mauritius or Mainland/Continental CM, and for which there is a lack of standard reference data such as hematology, coagulation, serum biochemistry, urinalysis, and urine chemistry results. In addition to compiling and comparing clinical pathology test results, this study also monitored clinical observations, body weight, and rectal temperature to assess animal health during blood and urine collection. The objective is to investigate selected hematology, serum biochemistry, coagulation, and urine parameters for Philippine-origin macaques and compare them with published reference data from Mauritius, Chinese, and Cambodian-origin CM.