Executive Summary

Selecting the appropriate nonhuman primate (NHP) model is a foundational decision in the preclinical development of next-generation therapeutics. A fragmented supply chain introduces significant timeline and animal cohort variability risks. Through a strategic integration with the Bioculture Group, Franklin Biolabs provides a secured, integrated supply of Mauritian origin SPF cynomolgus macaques, supported by U.S.-based quarantine services. This approach ensures cohort consistency for longitudinal in-life studies and accelerates study initiation for sponsors targeting global regulatory submissions under ICH guidelines.

Frequently Asked Questions

Mitigating Supply Chain Fragmentation

Historically, securing NHP models involved a fragmented, multi-vendor process that introduced significant program risk. Sponsors faced unpredictable timelines, inconsistent animal health profiles, and a lack of longitudinal cohort continuity. This model is incompatible with the accelerated development timelines required for novel therapeutics. Our strategic integration with the Bioculture Group directly addresses these challenges.

This integration provides a secure and transparent supply of Mauritian origin SPF cynomolgus macaques. Key components of this model include:

• Full Traceability: Complete oversight from the Mauritian breeding facilities to our >100,000 sq ft preclinical facility.

• U.S.-Based Quarantine: All animals undergo quarantine and conditioning at U.S.-based facilities, ensuring full compliance with regulatory import requirements and animal welfare standards.

• Reduced Variability: A single-source, purpose-bred colony minimizes the biological variability that can confound study results and require larger animal cohorts.

This supply chain security is a core component of our ability to move therapeutic candidates to IND within an 18-24 month timeline, a track record established by our core scientific team prior to the formal launch of Franklin Biolabs in 2024.

Consistent Models for In-Life Program Integrity

A secured supply chain enables a more robust preclinical strategy. Consistent animal models are a prerequisite for the integrity of any in-life study phase. Research into AAV vector interactions within NHP tissues highlights the complexity of these biological systems (PMID: 20113166). The use of genetically and environmentally consistent NHP cohorts is necessary to minimize confounding variables during in-life observation.

By providing well-characterized cohorts, we ensure that the biological system for the in-life study phase is as uniform as possible. This rigorous approach to preclinical model sourcing is part of the foundation that supports our work with leading innovators, including our leading industry partners. Our comprehensive Preclinical and Translational Services are designed to support the robust, GxP-compliant in-life studies required for successful submissions to the FDA and other global regulatory bodies.

Commitment to Animal Welfare

Our program operates under the highest ethical standards for animal welfare, with AAALAC International accreditation and adherence to USDA regulations. We are committed to the 3Rs Principle (Replacement, Reduction, and Refinement), employing enhanced housing conditions and cognitive enrichment programs to support the physiological and psychological well-being of all animals.