White Paper

Characterization Of The Sinclair Nanopig™ For Biopharmaceuticals Safety Assessment

Source: Altasciences

By Yafei Chen and Wendell P. Davis

GettyImages-924276310_pig

The safety and efficacy of human (bio)pharmaceuticals depend significantly on their interaction with therapeutic targets. For decades, the Sinclair minipig has been a valuable species in biomedical research. However, limited knowledge of its human orthologous targets has restricted its utility in preclinical studies, particularly those involving biologics. Recent advancements in whole genome sequencing (WGS), tissue-based proteomics, and cutting-edge bioinformatics have bridged the translational knowledge gap between minipigs and humans. These advancements have also facilitated the development of digital research tools to enhance the sustainability and quality of biomedical R&D.

Altasciences and Sinclair Bio Resources have introduced the Sinclair Nanopig™ as a next-generation non-rodent model for drug safety assessment. This new model has been characterized with reference values, including limited growth rates and lower body weight. Findings demonstrate comparable clinical pathology data, organ weights, and background microscopic observations to other minipig breeds (Chen et al., 2023). By combining genome-based comparisons of drug targets with quantitative tissue protein expression analyses, researchers can rationally predict pharmacological effects, cross-reactivity, and potential toxicities of human drugs in animal models. This approach improves clinical translation and reduces drug attrition (Vamathevan et al., 2013; Heckel et al., 2015).

A recently published white paper provides comprehensive genomic, proteomic, and functional characterization data for the Sinclair Nanopig™, focusing on metabolism and immune systems. This data supports the use of the Sinclair Nanopig™ as a human-relevant species for regulatory pharmacology and drug safety studies, while also advancing translational knowledge. These insights contribute to reducing reliance on traditional non-rodent models in drug development.

The Sinclair Nanopig™ characterization project was spearheaded by Altasciences in collaboration with Sinclair Bio Resources, the University of Missouri (Figure 1), and BioIVT (CYP450 enzymatic activity). Sequencing data for the Sinclair Nanopig™ genome and proteome (Chen et al., 2024) now enable cross-species assessments of pharmacology-related adverse effects. This breakthrough facilitates deeper understanding of drug metabolism and off-target toxicities, marking a significant step forward in preclinical research.

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