Preclinical | Translational

Preclinical and translational studies are crucial to the development of efficacious and safe new medicines. We support your needs from early-stage candidate screening using AAV vectors (or other advanced therapies) to GLP dose finding and toxicology studies with QA oversight. Additional services include histopathology and image analysis supporting the evaluation of safety/toxicology, vector tropism, and transgene expression for non-GLP and GLP studies. We support projects at every stage, from proof-of-concept to regulatory submission. Our experience includes submissions to the US FDA and international regulatory agencies.

For more information on the impact of animals in advancing biomedical research, please click here.

Our Expertise

The experience and expertise at Franklin Biolabs go beyond traditional CROs to support the development of your genetic medicine and deliver IND-ready reports. Franklin Biolabs performs GLP-compliant studies in house and does not rely on third-party laboratories to ensure end-to-end quality control and to save time and costs. Our experienced study directors engage with clients to design and execute studies tailored to each project’s specific needs.

We are able to conduct pharmacology studies for multiple advanced therapeutic modalities to evaluate efficacy, pharmacodynamics, and pharmacokinetics in disease models. Our team has technical and scientific expertise in highly specialized and clinically relevant routes of administration specific to cell and gene therapy products. We can also perform investigative pathology to elucidate mechanism(s) of action in the case of unexpected toxicity.

Candidate to IND in 18-24 months

Culture of Care

On-site Good Laboratory Practice (GLP)-compliant services available

Our Services

In Vivo Services

  • Animal model development

  • Various routes of administration for cell and gene therapies

  • Advanced surgical and diagnostic imaging techniques

  • Neurobehavioral and motor function tests

  • Expertise in array of study designs including pharmacology, efficacy, and pharmacokinetics

  • IND-enabling toxicology studies

  • End-to-end pathology platform with full-service histology, multiplex ISH capabilities, and a digital workflow

In Vivo Operations

Our dedicated team includes board-certified veterinarians, a board-certified toxicologist, and experienced technical staff. We provide comprehensive veterinary, clinical, animal care, and welfare services, including rodent colony management. Franklin Biolabs is committed to strict compliance with all applicable federal, state, and local regulations that govern the care and use of animals in biomedical research. We recognize and adhere to best practices in animal work, including a commitment to Reduce, Replace, and Refine the use of animals in research.