Integrated NHP Study Capabilities

Nonhuman primate (NHP) studies are often a critical component of preclinical development for cell and gene therapies, biologics, RNA therapeutics, and other advanced modalities. These studies can provide essential information on safety, pharmacology, biodistribution, immunogenicity, and biological activity before clinical evaluation.

At Franklin Biolabs, we design NHP studies around the specific questions each program needs to answer. Our scientists work closely with sponsors to develop study strategies that align with the therapeutic modality, mechanism of action, route of administration, target tissue, and stage of development. From protocol design and dose administration through sample analysis and data interpretation, our integrated teams provide the expertise needed to support informed development decisions.

By combining preclinical research, bioanalysis, immunogenicity testing, biodistribution assessments, clinical pathology, and histopathology within a coordinated program, we help sponsors generate a more complete understanding of therapeutic performance and potential risk.

NHP Pharmacology and PK/PD Studies

Understanding exposure and biological activity is essential when advancing a therapeutic candidate toward the clinic. Franklin Biolabs supports pharmacology and PK/PD studies designed to evaluate:

• Drug exposure and pharmacokinetics (PK)
• Pharmacodynamic (PD) responses
• Biomarker expression
• Target engagement
• Mechanism of action
• Dose-response relationships

Our integrated approach allows pharmacologic findings to be correlated with immunogenicity, biodistribution, and tissue-level effects, creating a comprehensive view of therapeutic activity.

NHP Toxicology and Safety Assessment

Franklin Biolabs conducts GLP and non-GLP toxicology studies to characterize safety profiles and identify potential treatment-related effects before clinical development.

Study capabilities include:

• Dose-ranging studies
• Repeat-dose toxicology studies
• IND-enabling safety assessments
• Clinical observations
• Body weight and food consumption monitoring
• Clinical pathology evaluations
• Necropsy and pathology assessments

Our team works with sponsors to develop study designs that meet regulatory expectations while generating data that support critical development milestones.

 

Biodistribution Studies in Nonhuman Primates

For many advanced therapies, understanding where a therapeutic distributes throughout the body is an important part of the nonclinical package.

Franklin Biolabs performs biodistribution studies to evaluate:

• Distribution to target tissues
• Presence in non-target tissues
• Persistence over time
• Dose-dependent tissue exposure
• Vector and transgene localization

Using molecular and tissue-based analytical approaches, we help sponsors characterize therapeutic distribution and support regulatory submissions.

 

Immunogenicity Assessment

Immune responses can influence therapeutic exposure, efficacy, and safety. Our immunogenicity team provides assays and study support to evaluate both humoral and cellular immune responses.

Capabilities include:

• Anti-drug antibody (ADA) testing
• Neutralizing antibody (NAb) assays
• Cellular immune response assessments
• ELISpot analysis
• Cytokine and biomarker evaluation

These endpoints can be integrated into broader NHP studies to provide a more complete understanding of therapeutic performance.

 

Bioanalytical Services for NHP Studies

Bioanalytical data play a central role in interpreting preclinical outcomes. Franklin Biolabs analyzes a wide range of biological matrices to support pharmacology, toxicology, and translational research objectives.

Sample types include:

• Blood and serum
• Plasma
• Cerebrospinal fluid (CSF)
• Tissue samples
• Urine and other biological matrices

Our laboratories support assays for:

• Pharmacokinetics
• Biomarkers
• Immunogenicity
• Biodistribution
• Vector quantification
• Program-specific endpoints

 

Clinical Pathology

Clinical pathology evaluations provide important insight into treatment-related effects and overall animal health during NHP studies.

Our capabilities include:

• Hematology
• Clinical chemistry
• Coagulation testing
• Urinalysis
• Specialized biomarker assessments

These data help support safety evaluations and provide context for pharmacologic and pathologic findings.

 

Histology and Histopathology

Histopathology is often critical for understanding the tissue-level effects of a therapeutic candidate.

Franklin Biolabs pathology team provides:

• Tissue collection and processing
• Histology and slide preparation
• Microscopic evaluation
• Pathologist interpretation
• Integrated pathology reporting

By correlating histopathology findings with clinical observations, bioanalytical data, and biodistribution results, sponsors gain a deeper understanding of therapeutic activity and safety.

 

Vector Shedding Studies

For gene therapies and other vector-based therapeutics, vector shedding assessments can be an important part of the nonclinical development program.

Franklin Biolabs supports vector shedding evaluations across relevant biological matrices, helping sponsors understand:

• Presence of vector material after administration
• Duration of shedding
• Patterns of distribution and clearance
• Nonclinical safety considerations

Our integrated analytical capabilities allow shedding data to be evaluated alongside biodistribution, PK, immunogenicity, and toxicology endpoints.

Why Sponsors Choose Franklin Biolabs for NHP Studies

Franklin Biolabs brings together scientific expertise, specialized analytical capabilities, and purpose-built infrastructure to support complex NHP research programs.

• Integrated pharmacology, toxicology, bioanalysis, immunogenicity, biodistribution, and pathology services
• GLP and non-GLP study support
• Experience supporting advanced therapeutics, including cell and gene therapy programs
• More than 1,300 NHPs dosed across multiple routes of administration
• Over 75,000 sq. ft. of USDA- and GLP-compliant animal facilities
• AAALAC-accredited and USDA-registered NHP facilities
• BSL-2/ABSL-2 capabilities, quarantine, and isolation space
• A campus spanning more than 100,000 sq. ft. designed to support advanced therapeutic development

Whether supporting exploratory research, translational pharmacology, or IND-enabling studies, Franklin Biolabs provides the integrated expertise sponsors need to generate meaningful data and advance promising therapies toward the clinic.