Franklin Biolabs applies proven intelligence in preclinical and translational development to accelerate both advanced therapeutics – including gene therapies, genome editing approaches, cell therapies, and RNA/LNP systems – and complex biologics. We provide clients with data-driven strategies to move from discovery to IND submission, operating as an embedded scientific extension focused on minimizing clinical risk.

Tailored Strategies for Complex Modalities

A standard preclinical testing template does not exist for these programs. Each asset requires a tailored strategy based on its specific modality, mechanism of action, and target indication. This involves a deep understanding of vector biology and the selection of appropriate models that accurately predict human outcomes.

Bridging the Gap: Animal Models to Human Outcomes

Our scientific foundation includes extensive work in vector engineering and evaluating cross-species translatability. Insights into how AAV capsid affinities for specific host cell receptors dictate tissue targeting, for example, directly inform how we design preclinical programs to account for critical differences between predictive animal models and human clinical subjects (PMID: 37199615). This level of detail is applied across all modalities to build robust, regulatory-compliant data packages meeting or surpassing recommendations from regulatory agencies (FDA, EMA/MHRA, and other global regulatory bodies) that reliably mitigate translational risk.

End-to-End Integrated Capabilities

Our integrated capabilities are structured to support the entire preclinical journey:

• Vector, CMC, and Analytics: Phase-appropriate process development for viral vectors, supported by rigorous analytical testing to ensure product characterization and consistency.
• Preclinical and Translational Services: IND-enabling toxicology studies conducted under GLP conditions, leveraging deep expertise in complex in vivo model development and execution.
• Bioanalytical Services: Development and validation of preclinical assays that can be routinely transitioned to be appropriate for clinical assessments for immunogenicity, biodistribution, and biomarker analysis to support safety and efficacy assessments.