The Species Selection to Deliver Translational Data

The wide genomic, proteomic, and anatomical variation between humans and other species is an inherent source of risk in preclinical studies. Mitigating that risk requires knowing what model – and what species – is the best to faithfully reproduce human physiology.

BioLegacy’s new, state-of-the-art facilities are designed to house a wide range of research species, and we maintain colonies of many species on-site. You can know that when you work with BioLegacy, species selection isn’t a matter of convenience, but a matter of scientific rigor.

If you would like a species you don’t see below, just ask. Our facilities can accommodate almost any species.

Small Animals

Comprehensive Small Animal Model Platforms

Small animal models are a cornerstone of preclinical drug discovery and development, providing the foundational data required to assess a new therapeutic’s safety and efficacy before it can advance to human trials. BioLegacy leverages a wide range of species — including mice, rats, guinea pigs, rabbits, and hamsters — to best recapitulate human disease biology. Spanning genetically engineered mouse models for oncology and immunology to the well-characterized systems of rats for safety pharmacology and the unique physiological advantages of guinea pigs for respiratory and auditory studies, we ensure your studies are positioned to provide maximum insight and minimize risk.

With hundreds of models, we provide the necessary breadth and depth of insights into your compound’s mechanism of action, pharmacokinetics, and toxicology. Work with BioLegacy, make confident go/no-go decisions, and build a strong foundation for your IND submission.

  • Diverse Species Portfolio:: We select the most scientifically appropriate model for your program.
  • Genetically Engineered Models (GEMs):: Extensive experience with transgenic, knockout, and humanized models for complex target validation and efficacy studies.
  • Comprehensive Disease Model Expertise:: Validated models across key therapeutic areas including oncology, immunology, inflammation, neurology, cardiology, metabolism, and more.
  • GLP-Compliant Safety & Toxicology:: Full IND-enabling safety, toxicology, and safety pharmacology studies conducted in accordance with global regulatory guidelines.
  • Advanced Technical & Surgical Skills:: Expertise in a wide range of administration routes, complex surgical models, and precise sample collection techniques.
  • Integrated Bioanalytical & Pathology Support:: Seamless in-house support for TK/PK sample analysis, biomarker quantification, and expert pathological interpretation.
  • AAALAC-Accredited Facilities:: All studies are conducted in a state-of-the-art, accredited vivarium, ensuring the highest standards of animal welfare and data quality.

Mice

Rats

Rabbit

Guinea

Hamsters

Mouse Studies

  • The genetic tractability of the mouse makes it a key model organism for interrogating complex, immune-mediated diseases, oncology, and more. BioLegacy’s capabilities with genetically engineered and humanized mice further allow for precise target validation and mechanism-of-action studies that are impossible or impractical in other species.

    • Immuno-Oncology & Syngeneic Models:: Expertise in tumor models with intact immune systems to assess checkpoint inhibitors, CAR-T, and other immunomodulators.
    • Genetically Engineered Models (GEMs):: Knockout, knock-in, and transgenic lines to study complex disease pathways across many therapeutic areas.
    • Humanized Mouse Models:: Platforms expressing human genes or reconstituted with human immune systems (e.g., huCD34+) for evaluating human-specific biologics.
    • Autoimmunity & Inflammation:: Robust, well-characterized models for autoimmune diseases like rheumatoid arthritis (CIA) and multiple sclerosis (EAE).

    Rats Studies

  • Well-characterized physiology and larger size make the rat the quintessential model for regulatory toxicology and complex functional assessments. BioLegacy specializes in leveraging rats for pivotal GLP-compliant safety pharmacology, advanced neurobehavioral paradigms, and studies requiring surgical instrumentation such as cardiovascular telemetry.

    • ICH-Compliant Safety Pharmacology:: Core battery assessments (CNS, respiratory) including continuous cardiovascular monitoring via implanted telemetry devices for precise hemodynamic and ECG analysis.
    • Advanced Neurobehavioral & Cognitive Testing:: Expertise in complex paradigms including operant conditioning, fear conditioning, and validated models of psychiatric and neurodegenerative disorders.
    • GLP-Compliant Toxicology & DART:: Robust platforms for IND-enabling repeat-dose toxicology and developmental/reproductive toxicity studies, enabled by superior toxicokinetic (TK) sampling capabilities.
    • Complex Surgical & Device Models:: Leveraging a larger surgical field for sophisticated models like middle cerebral artery occlusion (MCAO) for stroke research and the evaluation of implantable medical devices.

    Rabbit Studies

  • The rabbit model is essential for specific, regulatory-mandated safety assessments due to its unique predictive value in select biological systems. BioLegacy utilizes rabbits for their established utility in developmental and reproductive toxicology (DART), ophthalmology, and dermal irritation studies. Our expertise ensures the generation of the definitive, GLP-compliant data required to de-risk your program and fulfill key components of your IND submission.

    • Developmental & Reproductive Toxicology (DART):: Gold-standard model for embryo-fetal development (EFD) toxicity studies, meeting ICH S5(R3) guideline requirements.
    • Ophthalmology Studies:: A superior model for evaluating ocular therapeutics and devices due to the large size and anatomical structure of the rabbit eye.
    • Dermal & Irritation Studies:: Validated models for assessing dermal toxicity, irritation, and sensitization, providing critical data for topically applied compounds.
    • Antibody Production & Atherosclerosis:: Robust platforms for polyclonal antibody generation and well-established, diet-induced models of atherosclerosis.

    Guinea Pigs

  • The guinea pig model is a specialist among rodents, chosen when the scientific question demands a model that recapitulates specific human physiological responses in the lungs, ears, skin, or metabolism. Specific attributes, such as the bronchoconstriction response, cochlear anatomy, allergic hypersensitivity, and lack of L-gulonolactone oxidase, make guinea pigs more human-like in a number of important ways.

    • Respiratory & Allergy Models:: Models of induced asthma and airway hyperresponsiveness (AHR) with precise functional readouts.
    • Auditory System Studies:: Gold-standard models for assessing ototoxicity and the efficacy of therapeutics for noise-induced or age-related hearing loss.
    • Delayed-Contact Hypersensitivity (DCH):: Robust models for evaluating anti-inflammatory compounds.
    • Infectious Disease Expertise:: Vaccine and therapeutic efficacy studies for specific pathogens including M. tuberculosis.

    Hamsters

  • The Syrian hamster’s unique features make it a powerful model for specific therapeutic areas. Its immunologically privileged cheek pouch enables robust oncology xenograft studies. The hamster’s human-like lipid metabolism empowers translational research in dyslipidemia and atherosclerosis. BioLegacy’s expertise in harnessing the distinct traits of the hamster model delivers definitive efficacy data for these and other specialized programs.

    • Oncology & Xenograft Models:: Tumor cell implantation and therapeutic assessment utilizing the cheek pouch.
    • Metabolic Disease Studies:: Robust, diet-induced models that closely mimic human lipid metabolism and disease progression.
    • Infectious Disease & Virology:: Superior translational relevance in infections from coronaviruses and flaviviruses.
    • Reproductive Biology:: Superior to other rodents for certain teratology and reproductive toxicology studies due to its distinct placental structure and developmental timeline.
    Large Animals

    The Bridge to First-In-Human Trials

    Large animal models provide the highest degree of translational relevance to human physiology and are a crucial component of preclinical development for most drugs and medical devices. BioLegacy possesses deep expertise across a comprehensive range of large animal species, including non-human primates (NHP), canine, porcine and ovine models, to meet the rigorous demands of IND and IDE submissions. We leverage the unique anatomical and physiological advantages of each model, from the unparalleled predictive value of canines in regulatory toxicology and safety pharmacology to the human-like organ systems of swine and sheep for surgical and device evaluation, and the incomparable physiological and genetic similarities of NHPs. Our state-of-the-art facilities and expert scientific oversight ensure the generation of robust, GLP-compliant data packages designed to de-risk your program and satisfy global regulatory expectations.

    • Multi-Species Expertise:: In-house capabilities with non-human primates (NHPs), dogs, pigs / mini-pigs, and sheep to select the most scientifically and regulatorily appropriate model.
    • GLP-Compliant Toxicology & Safety Pharmacology:: Full IND-enabling programs conducted in strict adherence to FDA and international guidelines, including ICH S7A/B core battery assessments.
    • Advanced Surgical & Device Implantation: : World-class surgical suites and expertise for complex procedures, including the evaluation of cardiovascular, orthopedic, and neurological devices.
    • Non-Human Primate (NHP) Specialization:: On-site NHP availability for studies involving complex biologics, cell and gene therapies, vaccines, and others where human-like immunogenicity and metabolic pathways are critical.
    • Canine Toxicology Leadership:: The gold-standard non-rodent species for pivotal repeat-dose toxicology and toxicokinetic (TK) studies required for IND submission.
    • Integrated Large Animal Imaging:: Access to advanced imaging modalities (e.g., fluoroscopy, ultrasound) to support surgical procedures and assess device performance.
    • Dedicated Large Animal Care & Husbandry:: AAALAC-accredited facilities with experienced veterinary staff and enrichment programs to ensure the highest standards of animal welfare and data quality.

    Non-Human Primates

    Dogs

    Pigs/Mini Pigs

    Sheep

    Non-Human Primates

  • Non-Human Primates immunological, metabolic, and genetic parallels to humans make it pivotal for safety and efficacy studies in advanced therapeutics. BioLegacy’s expertise with complex biologics, cell and gene therapies, and vaccines delivers the definitive, translationally relevant data needed to de-risk your program before first-in-human trials.

    BioLegacy operates the only NHP facility in the southwest United States.

    • Complex Biologics & Immunogenicity:: Evaluate monoclonal antibodies, antibody-drug conjugates (ADCs), and other biologics, including comprehensive anti-drug antibody (ADA) assessments.
    • Cell & Gene Therapy Programs:: Specialized capabilities for biodistribution, shedding, and safety studies for advanced therapy medicinal products (ATMPs).
    • GLP-Compliant Safety & Toxicology: : IND-enabling toxicology and safety pharmacology studies designed to meet global regulatory requirements.
    • Specialized Technical & Surgical Expertise:: Precise dosing via multiple routes, complex surgical procedures, and intensive biological sampling.

    Dogs

  • As the mandated non-rodent species for many regulatory submissions, the canine model is core to toxicology and safety pharmacology. BioLegacy specializes in leveraging this well-characterized system to generate the robust, GLP-compliant data packages required for successful IND applications. Our expertise in cardiovascular safety, repeat-dose toxicology, and toxicokinetics provides the critical data needed to establish safety margins and confidently select first-in-human doses.

    • GLP-Compliant Toxicology:: IND-enabling repeat-dose toxicology studies with comprehensive clinical pathology and histopathology to meet global regulatory requirements (FDA, EMA, OECD, NMPA, etc.).
    • ICH S7A/B Safety Pharmacology:: Core battery assessments including cardiovascular safety via implanted telemetry for continuous ECG, blood pressure, and hemodynamic monitoring.
    • Integrated Toxicokinetics (TK):: Extensive, in-house bioanalytical capabilities to provide high-quality exposure data.
    • Medical Device & Surgical Models:: A preferred model for evaluating safety and performance in cardiovascular and orthopedic devices.

    Pigs / Mini-Pigs

  • Pigs provide the model of choice for many translational surgical research and medical device evaluation studies, as well as preclinical research into many cardiovascular and metabolic divisions, due to their profound anatomical and physiological parallels to humans, including organ size, skin structure, and cardiovascular systems. BioLegacy provides you with crucial safety, efficacy, and biocompatibility data for your device or therapeutic, underpinning strong IDE or IND submission.

    • Medical Device & Implantable Testing:: Deep expertise and hands-on surgical capabilities for implanting and evaluating cardiovascular (e.g., stents, valves), orthopedic, and surgical devices.
    • Translational Surgical Research:: State-of-the-art surgical suites and expertise for validating complex surgical techniques and procedures.
    • Dermatology & Transdermal Delivery:: A highly predictive model for dermal safety, absorption (PK), and wound healing studies.
    • Cardiovascular & Metabolic Disease:: Well-established models for research in atherosclerosis, myocardial infarction, and other cardiovascular and metabolic conditions.

    Sheep

  • The ovine model shares a number of human-like physiological characteristics which make it a choice model for medical devices, complex surgical procedures, and certain classes of therapeutics. BioLegacy leverages these translational advantages in orthopedics, cardiovascular medicine, reproductive/fetal safety studies, and others to ensure that your IND or IDE submission contains the most defensible efficacy, safety, and biocompatibility data.

    • Orthopedic & Bone Regeneration:: Evaluate orthopedic implants, bone grafts, and tissue engineering strategies through histological profiling in a species with bone mineral density and remodeling processes that parallel humans.
    • Cardiovascular Device Testing:: Implantation and long-term evaluation and monitoring of cardiovascular devices.
    • Maternal-Fetal & Reproductive Medicine:: Validated models for studying placental function, fetal development, and the safety of therapeutics during pregnancy.
    • Advanced Surgical & Interventional Models:: State-of-the-art surgical suites and technical expertise for developing and performing complex, long-term survival surgeries
    Other Animal Models

    The Skill & Flexibility to Meet Unique Needs

    BioLegacy’s offerings are not confined to a limited list of models; our fundamental understanding of comparative medicine enables us to work with the most translationally relevant biological system for any given therapeutic modality. Our new, state-of-the-art, multi-species vivarium is engineered with flexible housing and advanced environmental controls to accommodate diverse species. Our operations ensure ethical and timely acquisition of even the most uncommon or specialized models. BioLegacy’s broad scientific experience and operational agility combine to enable rapid design and quality execution of less standard in vivo studies that provide our partners with a critical scientific advantage.

    • Advanced Protocol Development & Refinement:: Extensive cross-species expertise in developing, refining, and validating novel in vivo models and protocols
    • Operational Excellence in Multi-Species Husbandry:: Skilled veterinary staff working in our new, state-of-the-art vivarium provide superior husbandry and veterinary care across a broad range of biological systems.
    • Integrated Logistical & Supply Chain Mastery:: Our global sourcing and procurement infrastructure mitigates logistical risks and accelerates study timelines by ensuring the reliable and ethical acquisition of research models.
    • Strategic Translational Model Selection:: Our PhD-level study directors identify and implement the most predictive biological system to answer your specific scientific questions.

    De-Risk Your Pipeline with Impeccable Models

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    Working with BioLegacy was a great experience. The team was very responsive and their dedication to my study was obvious. They caught a problem with our study design early on that could have resulted in serious flaws in our data, were able to suggest and execute protocol changes mid-study, and with minimal impact on cost and schedule. I would recommend BioLegacy to anyone!

    Dr. FirstName LastName

    Vice President of Department

    Example Pharmaceuticals