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Toxicology

Franklin Biolabs conducts robust toxicology studies to support development of your advanced therapy.

Preclinical Toxicology Solutions for Advanced Therapies

Franklin Biolabs offers a wide range of GLP and non-GLP toxicology options to suit the needs of your program. With decades of experience developing advanced therapies, we understand that simply applying a standard toxicology approach will not suffice. Our team brings deep insights from numerous successful IND submissions to global regulatory bodies to provide bespoke solutions to the unique challenges that can be encountered during clinical development. Franklin Biolabs is ready to design and execute standard and custom toxicology studies for your advanced therapy program.

>25
GLP toxicology studies completed
7
IND approvals in the last 6 years
>120
AAV vectors evaluated for CNS and systemic administration
>1,300
NHPs dosed via multiple routes of administration

Toxicology Services

Franklin’s experienced team comprises board-certified veterinarians, toxicologists, and study directors with expertise across multiple therapeutic areas, disease indications, and species. Our >75,000 sq. ft. state-of-the-art animal facility and support space is USDA and GLP compliant with BSL2/ABSL2 capabilities and includes dedicated space for quarantine and isolation. Franklin Biolabs is here to deliver toxicological evaluations tailored to your advanced therapy needs, whatever the modality or indication.

Our end-to-end toxicology service options:

  • Modalities
    • Gene therapy
    • Gene editing
    • Cell therapy
    • LNP-mRNA
    • Oligonucleotide and siRNA technology
    • Antibodies
    • Protein therapies
  • Routes of Administration
    • Parenteral (including intravenous/systemic, intramuscular)
    • Oral
    • Topical
    • Intracerebroventricular
    • Intracisternal magna
    • Intrathecal lumbar
    • Ocular (topical, intracameral, subconjunctival, intravitreal, subretinal, retrobulbar)
    • Intranasal
  • Bioanalysis
    • Immunogenicity
      • Neutralizing antibody
      • Anti-drug antibody assay
    • Shedding studies
    • Complement and cytokine activation immunogenicity assessment
    • Tumorigenicity and mutagenicity studies
    • Biodistribution
    • Biomarker analysis
  • Histopathology
    • Anatomical
    • Clinical
    • Imaging and digital pathology
    • Specialized necropsy
    • Routine and special stains
  • IND/CTA-Enabling Toxicology Studies (GLP)
    • Single and repeat dose toxicity
    • Dose range finding and pharmacology studies (non-GLP)
      • Maximum tolerated dose
      • Minimum effective dose
    • Long-term safety monitoring
    • Toxicokinetics
    • Pharmacokinetics/Pharmacodynamics
    • Safety pharmacology assessment
    • Local tolerance testing
  • Data Analysis, Interpretation, and Final GLP Reporting
    • Audited report (rapid delivery)
    • SEND Compliance
  • Regulatory Submission

Toxicology Therapeutic Areas

Rare Disease
  • Genetically engineered rodent disease models
  • Natural history studies
  • Biomarker analyses
  • Efficacy studies
  • Proof-of-concept studies
  • Dose identification studies
CNS
  • Behavioral and neurological assessment (rodents and large animals)
  • Experience with CNS rodent models
  • Natural history studies
  • Electroencephalogram (rodent and large animal telemetry)
  • Stereotaxic robotic surgery (rodents)
  • MRI- and CT-guided neurological platform for targeted delivery of therapeutic agents (ClearPoint® Neuro Systems)
  • Fluoroscopy and fluoroscopic
  • CNS delivery systems
  • Nerve conduction velocity
Ocular
  • Surgically altered animal models
  • Indirect and direct ophthalmoscopy
  • Slit lamp biomicroscopy
  • Optical coherence tomography
  • Electroretinogram
  • Fundus imaging
  • Tonometry
Cardiovascular
  • Electrocardiogram
  • Echocardiography
  • Telemetry
  • Cardiovascular imaging (MRI)
  • Cardiac safety biomarker analysis
Oncology
  • Orthotopic tumor implantation in vivo imaging systems (bioluminescence and fluorescence in rodents)
  • Ultrasound imaging
  • Computed tomography
  • MRI
Metabolic
  • Experience with neonatal-lethal mouse models
  • Natural history studies
  • Multiple liver biopsy procedures throughout in-life phase in NHPs
  • Metabolite analysis
  • Ultrasound imaging

Cutting-Edge Toxicology for Advanced Therapies

By engaging with Franklin, you get more than a CRO – you get a scientific and strategic partner. Together, we can develop targeted studies to carefully evaluate your advanced therapy in support of your specific aims, including globally aligned regulatory outcomes. We can execute sophisticated administration techniques relevant to the clinic. And throughout the process, the Franklin team will provide peace of mind via continuous project management communications that keep you updated every step of the way. Connect with our experts today to discuss your toxicology needs and accelerate your advanced therapy from the bench to the bedside.

Franklin Biolabs had dosed over 1,300 NHPs by different routes of administration:

  • 43% CNS
  • 40% Systemic
  • 9% Ocular
  • 8% Specialized routes including intra-articular and intrapulmonary

Looking to Scale Up
Vector Production?

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Enter the Clinic?

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Contact us for expert guidance and customized services tailored to your goals.

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