De-Risking Preclinical Timelines with an Integrated Nonhuman Primate Supply Chain
Securing consistent access to well-characterized nonhuman primate models presents a significant logistical challenge for sponsors of advanced therapeutics and complex biologics. Applying proven intelligence in preclinical toxicology, we have structured an integrated supply chain that directly mitigates this risk, accelerating program timelines from candidate selection to IND submission.
Our approach is built on a strategic integration with the Bioculture Group, guaranteeing access to Mauritian origin SPF cynomolgus macaques. This removes the uncertainty and competitive sourcing pressures that often delay the initiation of pivotal IND-enabling studies. The result is a predictable, secure, and fully compliant pathway for preclinical development.
The infrastructure required for next-generation therapies has fundamentally changed. As noted by our supply chain colleagues, “The value chain is diversifying… we are no longer just dealing with a pill in a bottle. We are dealing with living cells, with viral vectors, and the infrastructure has to adapt to that reality.” This adaptation is reflected in our dedicated U.S.-based quarantine and regulatory-compliant import clearance processes, which form a secure bridge from sourcing to study initiation.
The selection of an appropriate preclinical model is foundational for generating translatable data. For instance, the discovery of novel AAV serotypes from nonhuman primate models has been instrumental in developing vectors that can circumvent pre-existing human immunity—a critical hurdle for clinical success (PMID: 12192090). A science-based preclinical strategy, using models with an immune system that closely mirrors human response, is necessary to generate a data package that withstands regulatory scrutiny.
The operational benefits of this integrated model include:
- Supply Chain Security: Guaranteed access to high-quality, naive nonhuman primate models, reducing the risk of study delays.
- Full Traceability: Complete oversight from the breeding colony in Mauritius to our U.S.-based facilities.
- Regulatory Compliance: All import and quarantine procedures are managed to ensure full compliance.
- Enhanced Animal Welfare: Models are housed under enriched conditions with programs for cognitive and social well-being.
This infrastructure supports the work of our core scientific team. This team established a track record that includes a 100% successful IND rate since 2019 and a consistent ability to support sponsors in reaching the clinic within an 18-24 month timeframe prior to the launch of Franklin Biolabs in 2024.
