Comparison of Safety Pharmacology End Points in Cynomolgus Monkeys

This technical report presents a comparison of safety pharmacology endpoints used in toxicology studies involving cynomolgus macaques from different origins, specifically focusing on the Philippine population. The study addresses the increasing demand for cynomolgus macaques in biotherapeutic development and the necessity to explore underutilized origins due to global factors such as the COVID-19 pandemic. The report outlines the collection of safety pharmacology data, including electrocardiograms, blood pressure, blood gases, and respiratory rates from Philippine, Mauritius, and mainland/Continental cynomolgus macaques. The data was collected under controlled conditions and analyzed to determine the comparability of physiological parameters across these origins. The findings indicate that there are no significant differences in cardiovascular, respiratory, or body temperature values among the different origins, suggesting that Philippine cynomolgus macaques can be considered a viable option for regulatory toxicology assessments. This validation supports further detailed safety pharmacology evaluations in this population.