Preclinical | Translational Services

We support projects at every stage, from
proof-of-concept to regulatory submission.

End-to-End Preclinical Services from Candidate Screening to IND‑Enabling GLP Studies

Preclinical and translational research plays a vital role in bringing safe, effective therapies to market. We offer comprehensive support, from early-stage candidate screening using AAV vectors or other advanced modalities to GLP-compliant dose-ranging and toxicology studies with rigorous QA oversight.

Our services also include histopathology and image analysis to evaluate safety, vector tropism, and transgene expression in both non-GLP and GLP settings. With proven experience in regulatory submissions to the US FDA and international agencies, we are well-equipped to help advance your therapeutic programs with confidence.

Engage Our Scientists and Industry Leaders

Our expertise goes beyond traditional CROs to support the development of your advanced therapies and deliver IND-ready reports. We perform GLP-compliant studies in-house and do not rely on third-party laboratories. This ensures end-to-end quality control, as well as time and cost savings. Our experienced study directors engage with you to design and execute studies tailored to each project’s specific needs.

Candidate to IND in 18‑24 months

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

Over 75,000 sq. ft. of animal facility space featuring flexible housing design

In Vivo Services

We offer a robust suite of preclinical services to support the development of advanced therapeutics, including cell and gene therapies. Our services include a variety of administration routes and utilize advanced techniques to ensure precise delivery and monitoring.

Our in vivo services include:

Development of customized animal models
Multiple routes of administration for cell and gene therapies
Advanced surgical procedures and diagnostic imaging techniques
Neurobehavioral and motor function assessments

Development of customized animal models
Multiple routes of administration for cell and gene therapies
Advanced surgical procedures and diagnostic imaging techniques
Neurobehavioral and motor function assessments
Expertise in diverse study designs, including pharmacology, efficacy, and pharmacokinetics
IND-enabling toxicology studies under GLP conditions
A fully integrated pathology platform featuring full-service histology, multiplex ISH, and a streamlined digital workflow

Expertise in diverse study designs, including pharmacology, efficacy, and pharmacokinetics
IND-enabling toxicology studies under GLP conditions
A fully integrated pathology platform featuring full-service histology, multiplex ISH, and a streamlined digital workflow

These capabilities are designed to deliver accurate, reproducible data that accelerate your path to the clinic.

Animal Studies

We deliver full-spectrum preclinical research services in rodent and nonhuman primate (NHP) models, supporting the evaluation of efficacy and safety for emerging advanced therapies. Our capabilities include expert veterinary care, development of specialized animal models, advanced diagnostic imaging, and neurobehavioral assessments. We are proud to offer accelerated study initiation for NHP models, often outpacing typical industry timelines.

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In Vivo Operations

Our experienced team includes board-certified veterinarians, toxicologists, and skilled technical staff who deliver expert veterinary, clinical, animal care, and welfare services—including rodent colony management. At Franklin Biolabs, we provide exceptional routine and specialized care for over 8 laboratory animal species and are dedicated to the health and well-being of the lab animals that are involved in our research programs.

Ethics Statement

Franklin Biolabs is committed to strict compliance with all applicable international, federal, and local regulations that govern the care and use of lab animals in biomedical research. We recognize and adhere to best practices in lab animal work, including a commitment to Reduce, Replace, and Refine the use of lab animals in research.

Pathology Services

We offer full-service pathology support to advance your preclinical studies with precision and efficiency. Our integrated platform includes expert histology, multiplex in situ hybridization (ISH), digital image analysis, and pathology review—available for both non‑GLP and GLP‑compliant programs.