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Non-Human Primate Studies

Incomparable Translational Relevance for Critical Therapeutic Assets

For today’s most advanced therapeutics — including complex biologics, cell and gene therapies, and vaccines — the cynomolgus non-human primate (NHP) model is the indispensable bridge to human clinical trials. BioLegacy leverages NHPs profound immunological, metabolic, and genetic parallels to humans for sponsors’ most critical safety and efficacy studies. Our expertise in navigating the complexities of NHP research ensures the generation of definitive, translationally relevant data to de-risk your most innovative programs and meet the stringent expectations of global regulatory agencies.

BioLegacy maintains an on-site, AAALAC-accredited non-human primate colony, ensuring that studies can be initiated rapidly without the significant delays often associated with sourcing. Combined with our experienced scientific and veterinary staff, BioLegacy provides unparalleled skill and agility in study design and execution, providing sponsors with a clear, predictable path to confident first-in-human dose selection and successful IND submissions.

  • On-Site NHP Colony: Immediate availability of research-naive and characterized rhesus macaques for accelerated study initiation.
  • GLP-Compliant Toxicology & Safety: Full IND-enabling safety, toxicology, and safety pharmacology programs conducted in strict adherence to global regulatory guidelines.
  • Complex Biologics & Immunogenicity: Deep expertise in evaluating monoclonal antibodies, antibody-drug conjugates (ADCs), and other biologics, including comprehensive anti-drug antibody (ADA) assessments.
  • Cell & Gene Therapy Expertise: Specialized capabilities for biodistribution, shedding, and safety studies for advanced therapy medicinal products (ATMPs).
  • Advanced Dosing & Surgical Procedures: Highly experienced team for precise dosing via multiple routes (e.g., intravenous, intrathecal) and complex surgical implantation of medical devices.
  • Specialized Efficacy Studies: Expertise in conducting targeted studies neurological, ophthalmological, immunological, and infectious disease therapeutics
  • Intensive PK/PD Sampling: Proficient in performing serial and intensive sampling protocols to generate robust pharmacokinetic and pharmacodynamic data.
  • Unwavering Commitment to Animal Welfare: AAALAC-accredited facilities with comprehensive enrichment programs and dedicated veterinary oversight.
Get the Most Definitive GLP Data

BioLegacy provides sponsors with conclusive GLP data by conducting NHP studies within a framework of rigorous regulatory compliance and scientific excellence. Our IND-enabling program is executed in strict adherence to FDA, OECD, and ICH guidelines. By combining the unparalleled translational relevance of the NHP model with an unwavering commitment to data integrity, we provide the unimpeachable safety and toxicology data package required to de-risk your therapeutic and ensure the utmost confidence at every stage of regulatory review.

  • Full Compliance: FDA 21 CFR Part 58 and OECD GLP.
  • Independent Quality Assurance Unit (QAU): Phase inspections and data audits to ensure compliance and data integrity.
  • IND-Enabling Studies: Repeat-dose toxicology, safety pharmacology, and DART (Developmental and Reproductive Toxicology) studies required for IND submissions.
  • Regulatory Submission-Ready Reports: Generation of detailed, high-quality final reports designed to meet the expectations of global regulatory agencies.
  • Regulatory-Compliant SEND Datasets: Submission-ready SEND (Standard for Exchange of Nonclinical Data) packages designed to ensure FDA compliance and streamline regulatory.
  • Validated Analytical Support: Fully integrated, GLP-compliant bioanalytical support for toxicokinetic (TK) and immunogenicity (ADA) sample analysis.
  • Extensive Regulatory History: Proven track record of successful study submissions to global regulatory agencies, including the FDA, EMA, PMDA, and NMPA.
A Leader in Bioethics & NHP Animal Welfare

Exceptional science is inseparable from exceptional ethics. BioLegacy’s leadership in non-human primate welfare is reflected in a comprehensive husbandry program that goes beyond basic regulatory compliance. We are committed to the principles of the “3Rs” (Replacement, Reduction, and Refinement), ensuring studies are conducted with the utmost respect for our animals. Our husbandry practices are designed to support the complex psychological and social needs of NHPs, because their well-being is not only an ethical imperative but is also essential for generating robust, reliable, and translatable scientific data.

  • AAALAC International Accreditation
  • IACUC Oversight
  • Comprehensive Veterinary Care from board-certified veterinarians.
  • Social Housing & Enrichment provides opportunities for species-typical behaviors, including foraging, climbing, and socialization.
  • Specialized Staff & Training dedicated to NHP care and handling
  • Positive Reinforcement Training (PRT) trains animals to cooperate voluntarily with common procedures, reducing stress and improving well-being.
  • Transparent Operations: Sponsor site visits and full transparency into our animal welfare programs.
De-Risking the Most Advanced Therapies

As therapeutic innovation moves toward complex biologics, including antibody-drug conjugates (ADCs), and advanced therapy medicinal products (ATMPs), predicting human safety and efficacy becomes exponentially more complex. De-risking these programs requires a translational model with profound immunological and physiological fidelity to humans. BioLegacy specializes in designing and executing NHP studies that interrogate the risks of novel modalities, from immunogenicity and cytokine release to biodistribution and on-target toxicity, providing the data you need to confidently proceed to clinical trials.

  • Complex Biologics & ADCs: We evaluate all formats (mAbs, bispecifics, ADCs, etc.), including comprehensive immunogenicity (ADA/NAb) and PK/PD characterization.
  • Gene & Cell Therapy / ATMP Programs: Safety, biodistribution, and shedding studies for AAV, lentiviral, and cellular therapy platforms.
  • Cytokine Release Syndrome (CRS) Assessment: In vitro screening and in vivo monitoring capabilities to evaluate and mitigate the risk of CRS.
  • Integrated Biomarker & Bioanalytical Support: In-house ligand-binding (MSD, ELISA) and flow cytometry platforms to correlate exposure with pharmacodynamic response.
  • Targeted Therapeutic Area Expertise: Proven NHP models in immunology, infectious disease, neuroscience, and ophthalmology to assess efficacy for advanced therapeutics.
We just expanded our facilities!

See why BioLegacy is one of the fastest growing CROs in the United States.

  • On-site NHP colony
  • Industry-leading animal husbandry
  • New, state-of-the-art facilities
  • Extensive on-site bioanalytical capabilities
  • Rapid study initiation - usually 2 weeks or less!

Contact us today and let’s get the data you need.