From discovery toxicology to GLP-compliant, IND-ready studies, BioLegacy provides a full suite of toxicology and safety pharmacology services. We test your therapeutic’s effect on all vital systems, including central nervous, cardiovascular, and respiratory system functions. Our expertise in acute, subchronic, and chronic toxicity studies ensures a comprehensive safety profile to confidently advance your program to the clinic.

Understand pharmacokinetics and pharmacodynamics in the most pertinent animal models. Combined with BioLegacy’s decades of experience conducting in vivo pharmacology studies and our comprehensive bioanalytical capabilities, we offer superior data quality. GLP studies enable rapid IND turnaround.

Don’t let an imperfect model compromise your preclinical data. BioLegacy’s expertise in model development utilizes a vast toolkit — including transgenics, mutations, xenografts, and chemical or surgical induction — to deliver a model precisely engineered for your therapeutic’s mechanism of action or target area. Ensure the relevance of your preclinical data with the perfect model, developed just for your trials.

Led by one of the world’s top veterinary surgeons, and supported by a top-quality surgical suite, BioLegacy has the capability to perform the most difficult medical device microsurgeries for implantable devices. Our expertise extends to all classes of medical devices: diagnostic devices, therapeutic devices, and assistive devices. Let BioLegacy guide you smoothly to IDE.

BioLegacy’s in vitro screening provides deep mechanistic insight. We have a diverse array of physiologically relevant, cell-based assays to interrogate complex disease biology and precisely define your compound’s therapeutic activity. Validate translatable pharmacodynamic biomarkers, confirm target engagement, elucidate downstream pathway effects, and identify leads confidently with BioLegacy.

BioLegacy excels in developing bespoke in vitro assays to interrogate your hit compounds’ mechanism of action, efficacy, or toxicity. Leveraging our deep expertise in cell-based assays and bioanalysis, we build, optimize, and validate custom functional assays from the ground up to provide the precise, decision-driving data your pipeline demands.

Scale your operations without costly facility and staff expansion! Take advantage of our recently remodeled, state-of-the-art, 18,000 square-foot vivarium, built to AAALAC standards. It utilizes a compliant monitoring system which monitors, records and controls temperature, humidity, pressure and access. This facility has the capability of housing small and large animals including mice, rats, guinea pigs, hamsters, rabbits, goats, sheep, swine, dogs, non-human primates, and more.

BioLegacy turns tissue into definitive preclinical data with our comprehensive histology services, from routine H&E to advanced IHC. Get critical insight into your compound’s efficacy, target engagement, and safety profile. Through digital pathology and both GLP and non-GLP service, we deliver objective, reproducible data to empower confident, data-driven decisions and accelerate your program toward IND.

BioLegacy’s extensive portfolio of translationally relevant oncology models includes xenografts and syngeneic tumors spanning all major cancer types. Orthotopic cancer models are also available. With expert study design and advanced biomarker analysis, we deliver definitive efficacy, toxicology and mechanism-of-action data to de-risk your program and accelerate your most promising candidates.

BioLegacy’s robust portfolio of in vivo inflammation and autoimmune disease models and expert study design provide definitive answers to complex immunological questions. Characterize the efficacy, toxicology, and mechanism of action of novel biologics and small molecules, as well as their impact to safety and efficacy. Accelerate your program’s path to the clinic with GLP or non-GLP studies.

BioLegacy interrogates complex neurological pathways with robust in vivo models and cell-based assays to de-risk your CNS pipelines. Our models for neurodegenerative, neuroinflammatory, and other CNS diseases are coupled with sensitive neurobehavioral assessments and biomarker analysis to deliver clear, actionable data. Get reliable, IND-ready PK/PD and efficacy data.

BioLegacy’s robust in vivo models, imaging and hemodynamic analysis capabilities, and surgical expertise make us a powerful partner for studies on cardiovascular therapeutics and medical devices. Capable of performing GLP, IND/IDE-enabling studies in species from mice to NHPs, and with deep experience in both cardiac and peripheral indications, BioLegacy will provide you with reliable data when it is most needed.

Leveraging clinically relevant models of psoriasis, atopic dermatitis, wound healing, and more, BioLegacy provides you with quantitative data to validate your dermatological therapeutics. Our expertise in histopathology, cytokine profiling, and advanced imaging provides a definitive assessment of tissue repair and immunomodulation. Get a clear evaluation of your dermatological compound’s efficacy with BioLegacy.

Metabolic flux. Hormonal regulation. Glucose homeostasis. Understanding the biomarkers of metabolism is critical for advancing your therapeutic. BioLegacy’s diet-induced and genetic models of obesity, diabetes, MASH and other metabolic diseases build a safe transition to human conditions, while our powerful, updated bioanalytical capabilities provide reliable and sensitive readouts. BioLegacy will give you the necessary data to confidently clear the laggards and retain the winners in your metabolism pipeline.

BioLegacy’s preclinical platforms deliver clear mechanistic insights. With robust DSS- and TNBS-induced colitis models to in vivo gastric healing, food consumption, irritation and more, we provide a definitive assessment of your compound’s effect on food consumption, barrier integrity, and inflammation. Quantitative histopathology, multiplex cytokine analysis, and other bioanalytical tools generate the data you need to advance your GI therapeutic.

BioLegacy delivers definitive data on hepatotoxicity and therapeutic efficacy using gold-standard NASH, fibrosis, and acute injury models. By integrating quantitative histopathology (such as NAFLD Activity Score) with key biomarker analysis, we provide a clear, comprehensive, IND-ready assessment of your compound’s hepatoprotective potential.

Fully characterizing your respiratory therapeutic means going beyond simple endpoints. BioLegacy provides definitive, holistic data including airway hyperresponsiveness, inflammation, and fibrotic remodeling from our robust asthma, COPD, IPF, and other models. Integrated functional readouts, bronchoalveolar lavage analysis, and quantitative histopathology, support our leading bioanalytical capabilities to provide you with conclusive data

BioLegacy provides gold-standard CLP-induced and LPS-induced models to rigorously evaluate your therapeutic. Our ability to precisely measure systemic cytokine release biomarkers of multi-organ dysfunction gives you a deeper mechanistic understanding of your compound’s efficacy than basic survival endpoints. Studies with BioLegacy will provide you with a clear, translational profile of your compound’s immunomodulatory efficacy from which you can confidently progress your sepsis pipeline.

Accurately assessing therapeutics and medical devices for bone disorders requires specialized, translatable models in clinically relevant species. BioLegacy provides definitive assessments of bone safety using small and large animals to balance practicality and physiological similarity. Integrating advanced in vivo imaging, biomechanics, and histomorphometry, we clarify your compound or device’s impact on structural integrity and tissue repair.

BioLegacy provides definitive insights for nephrology and urology drug and device development through robust in vivo models, including acute kidney injury (AKI), 5/6 nephrectomy, and chronic kidney disease (CKD), as well as kidney fibrosis (Unilateral Ureteral Obstruction, UUO) and diabetic nephropathy models.

By measuring key biomarkers such as BUN, creatinine, and albuminuria, together with quantitative histopathology, flow measurement and urodynamic assessments, we deliver a comprehensive profile of your therapeutic’s renoprotective or cystoprotective potential.

De-risk your small molecules, biologics, cell/gene therapies, vaccines, and implantable devices with the most human-like physiology outside of the clinic. BioLegacy’s NHP expertise ensures definitive safety, efficacy, and PK/PD data. Start your studies quickly, get IND-ready data, and confidently advance your program to first-in-human trials.

Harnessing the power of murine genetics is key for early discovery and translational science. BioLegacy provides deep expertise in genetically engineered models (GEMs), humanized mice, and induced models for studies from target validation through GLP efficacy. With a huge range of models and indications, along with custom model development, BioLegacy is equipped to take your pipeline from early discovery to IND submission.

Canines are pivotal for regulatory-driven GLP toxicology and safety pharmacology as a required non-rodent species for many modalities. BioLegacy generates GLP-compliant data packages for both small molecules and biologics. We deliver critical cardiovascular, CNS, PK/TK, and safety readouts essential for confident IND submission and first-in-human dose selection.

The porcine model’s human-like anatomy and physiology make it an excellent selection for many translational applications including medical device and dermal studies. BioLegacy leverages these translational advantages for cardiovascular, dermal, orthopedic device and general toxicology testing. Our deep expertise, including industry-leading surgical capabilities, ensures you receive definitive data on device safety, biocompatibility, and functional performance critical for IDE submission.

Rabbit models are essential for specific, regulatory-driven safety assessments and antibody production. BioLegacy also leverages this species for its predictive utility in developmental and reproductive toxicology (DART), and specific disease states such as ophthalmology and dermal irritation where rabbits offer superior translational relevance compared to other species. Get the definitive, compliant data required for successful IND submission with BioLegacy.

Superior to mice for most medical device and cognitive / behavioral testing, the rat model is a cornerstone of preclinical toxicology, pharmacology, and medical device studies. BioLegacy commonly uses this robust model system for definitive PK/PD, safety pharmacology, and repeat-dose toxicology studies. Complemented by our expertise in complex surgical and neurological models, BioLegacy’s rat studies provide critical safety and efficacy data in your IND-enabling and IDE-enabling studies.

Large size and certain human-like physiological traits make the ovine model excellent for translational device and surgical research. BioLegacy leverages these advantages for orthopedic, cardiovascular, and other device studies. Sheep also provide a powerful, translational platform for maternal-fetal medicine studies. Empower your program with definitive data on device integration, surgical technique efficacy, and reproductive safety using BioLegacy’s ovine models.

Guinea pigs are prized over other rodents for having auditory, respiratory, and immune systems which are more similar to humans in many ways. BioLegacy uses guinea pigs in hearing loss studies, asthma and allergy models, dermal toxicology, and the testing of drugs and vaccines against certain infectious diseases. Use of guinea pigs may be less common than in the past, but they are an important component of BioLegacy’s holistic animal model offerings. The FDA has been increasingly accepting guinea pigs as the non-rodent species to satisfy the IND submission requirements when physiological relevance can be demonstrated.

Hamsters provide unique biological advantages. Their immunologically privileged cheek pouch offers an ideal site for xenografts, while their human-like lipid metabolism makes them uniquely suitable for atherosclerosis and metabolic disease research. BioLegacy provides GLP and non-GLP hamster studies to ensure that our clients have the most translationally relevant models for these therapeutic areas.

Some diseases are most accurately modeled using other species. The first gene therapy product to be approved by the FDA or EMA (Glybera, for Familial Lipoprotein Lipase Deficiency), did its preclinical studies in cats. If you need another species or animal model, please let us know. Our vivariums are built to accommodate almost all species used in IND submissions, and we can provide custom model development. BioLegacy can serve your uncommon animal model needs.

Your IND submission requires unimpeachable data delivered with speed. BioLegacy provides comprehensive, GLP-compliant toxicology and safety pharmacology programs with accelerated report timelines. With our trusted partner constructing your reports in submission-ready SEND state, we ensure regulatory compliance and streamline FDA review, helping you confidently advance your program to the clinic faster.

BioLegacy is prized by sponsors for the quality and capacity of its AAALAC-accredited vivarium. Our Housing services provides you access to our expert vivarium staff procedure and surgical suits and a piece of mind that the animals are cared for. In addition to fully outsourced studies, we also provide vivarium rental with customizable tiers of support.

BioLegacy boasts the most advanced and well-equipped bioanalytical laboratories of any CRO in Southern California and the Southwestern United States. Our comprehensive, GLP-compliant bioanalytical services – including PK/PD, immunogenicity (ADA, Nab), CK and phenotyping – quantify pharmacodynamic responses, measure key biomarkers, and elucidate drug metabolism. Using LC-MS/MS, MSD, flow cytometry, qPCR, and more, we deliver the precise, reliable results needed to advance your program with confidence.