Franklin Biolabs Achieves CLIA Certification for AAV NAb Testing
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Toxicology
Franklin Biolabs conducts robust toxicology studies to support development of your genetic medicines and biologics therapies.
Preclinical Toxicology Solutions for Genetic Medicines and Biologics
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.
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 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
- Immunogenicity
- 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
- Genetically engineered rodent disease models
- Natural history studies
- Biomarker analyses
- Efficacy studies
- Proof-of-concept studies
- Dose identification studies
- 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
- Surgically altered animal models
- Indirect and direct ophthalmoscopy
- Slit lamp biomicroscopy
- Optical coherence tomography
- Electroretinogram
- Fundus imaging
- Tonometry
- Electrocardiogram
- Echocardiography
- Telemetry
- Cardiovascular imaging (MRI)
- Cardiac safety biomarker analysis
- Orthotopic tumor implantation in vivo imaging systems (bioluminescence and fluorescence in rodents)
- Ultrasound imaging
- Computed tomography
- MRI
- 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 Genetic and Biologic 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 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
Meet Our Expert
Gourav Roy Choudhury, PhD, DABT
Senior Director, Toxicology
Dr. Gourav Roy Choudhury is a Board-Certified Toxicologist (DABT), veterinarian, and translational research leader with more than 15 years of experience advancing innovative therapeutics from discovery through clinical development. His expertise spans nonclinical safety assessment, regulatory toxicology, and preclinical development of biologics, gene therapies, cell therapies, and emerging therapeutic modalities.
Dr. Roy Choudhury has extensive experience leading GLP and non-GLP toxicology programs in rodent and nonhuman primate models to support FDA Investigational New Drug (IND) submissions. As a Study Director and scientific lead, he has guided complex safety programs involving AAV-based gene therapies, lipid nanoparticle platforms, in vivo CAR-T therapies, and other advanced biologics, with expertise in study design, dose selection, biodistribution, safety assessment, biomarker development, and regulatory strategy.
Currently, Dr. Roy Choudhury serves as Senior Director of Toxicology at Franklin Biolabs, where he provides scientific leadership for multidisciplinary teams developing next-generation therapeutic platforms. Previously, he held leadership roles at the University of Pennsylvania’s Gene Therapy Program, directing nonclinical safety programs that supported the advancement of CNS-targeted and systemic gene therapy programs into clinical development.
Dr. Roy Choudhury brings a unique combination of expertise in toxicology, neuroscience, veterinary medicine, and translational science, enabling effective collaboration across pharmacology, pathology, bioanalytics, regulatory affairs, and clinical development teams. His research contributions have been published in leading peer-reviewed journals and have helped advance transformative therapies for rare and neurological diseases.
He holds a Ph.D. in Pharmacology and Neuroscience from the University of North Texas Health Science Center and is a Diplomate of the American Board of Toxicology.
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