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Nonclinical Solutions for

Therapeutic areas

Specialized science that uncovers deep insight into your therapeutic area.

Tailored solutions for your therapeutic

Your mission is to advance innovative medicines for patients in your targeted therapeutic area. That means you may require nonclinical studies tailored to your particular modality, route of administration and proposed mechanism of action. Find standard nonclinical capabilities to support development in any therapeutic area coupled with deep, science-driven specialized solutions when focused support and guidance is required.

Cardiovascular

Get answers on efficacy and safety with nonclinical cardiovascular (CV) assessment techniques with access to telemetered models and experienced staff to design and conduct your studies using cutting-edge technology in our state-of-the-art telemetry facilities.

  • Options to integrate CV testing with toxicology studies
  • In vitro CV assessments with patch clamp electrophysiology
  • ICH Q&A-compliant hERG and in vivo QT testing
  • Variety of innovative vascular delivery methods (24/7 continuous and intermittent infusion, and slow bolus injection techniques) for rodent and non-rodent models
  • Wide range of species for CV assessments


Immunology  

We offer the full spectrum of immunology endpoints including in vitro pharmacology, safety assessment of immuno-modulatory drugs and translation of assays into human immunology.

  • Disseminated origins, access to commercially generated humanized mouse models or client-generated models for discovery immuno-oncology and immunotherapy
  • Immunology and immunotoxicology solutions for large molecule, small molecule and advanced therapy safety assessment including T-cell-dependent antibody
  • Endpoints for safety and efficacy: receptor occupancy, custom flow cytometry panels and biomarkers for GLP and non-GLP safety assessment and immunotoxicity, translational assays
  • Extensive experience characterizing cell-based therapeutics to regulatory requirements, including strength, purity, concentration, identity and stability of cell-based test articles
  • Flow cytometry, immunoassay and cell-based assays designed to fit your program’s needs
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Immuno-oncology

Immuno-oncology has rapidly expanded in importance in oncologic drug development. With cutting-edge laboratories and experienced scientists, you’ll stay at the forefront of novel preclinical assay development and validation covering a wide range of immuno-oncology modalities.

  • Experience with traditional bispecific antibody engagers to state-of-the-art chimeric antigen receptor-expressing cell-based therapies

  • Bispecific antibody support: receptor occupancy, custom flow cytometry panels and biomarkers for GLP and non-GLP safety assessment and immunotoxicity, translational assays

  • Chimeric antigen receptor (CAR T or CAR NK) cell therapy support: primary and immortalized cell culture, cryopreservation and revival, dose formulation and analysis support for toxicology studies, cytokine-independent growth assays, tissue cross reactivity and specialty immunohistochemistry to assess potential for off-target tissue binding

  • Assay development and validation: peripheral and tissue-specific immunophenotyping analysis by flow cytometry, biomarker analysis by ligand-binding assays, functional analysis by cell-based assays

  • Dedicated drug development and regulatory strategists to provide guidance and refine your nonclinical development plan

  • Full range of bioanalytical assay support for immunomodulatory endpoints

  • New approach methodologies (NAMs) for pharmacology and safety testing via organ-on-a-chip and in vitro assays for appropriate oncology physiology

  • Full portfolio of in vivo pharmacology models

  • In vivo tumor inoculation: tumor cell line culture, expansion and implantation

Infectious disease  

The continued rise in difficult-to-treat infections and deaths caused by multidrug-resistant pathogens reinforces the need to develop safer, more robust, and more effective therapies and vaccines against emerging and re-emerging diseases. With the advent of new vaccine technologies (recombinant proteins, live attenuated viruses, live vectors, DNA and RNA vaccines) coupled with novel adjuvants, formulations, dosing routes and delivery systems, there is an enhanced complexity and challenge in demonstrating safety and efficacy during nonclinical development of vaccines. 

  • Infectious disease and vaccine leaders offer deep knowledge in nonclinical development to prevent and treat bacterial, viral, fungal and parasitic infections 

  • Four decades of experience in discovery vaccine testing working with a variety of vaccine types and offering a full range of in vivo and in vitro services

  • Immunogenicity studies and vaccine challenge studies available

  • Comprehensive services for antimicrobial development, including a wide range of validated in vivo models complemented by full in vitro support

  • With guidance in selecting the appropriate model system to acquiring information on the immunogenicity of vaccine antigens for determining characteristics critical to your vaccine’s success, you’ll get quality data and insights to meet your timelines

  • Stand-alone in vitro assays to investigate efficacy against a wide range of bacterial and fungal pathogens 

  • AAALAC-accredited ABSL-2 containment facilities

  • Biodistribution and LNP analysis

  • Dose formulation considerations

Neuro Science

Neuroscience

The intricacies of and complex access to the central nervous system pose unique challenges in drug development. Our team offers deep neurodegenerative disease experience and knowledge, including in Alzheimer's and Parkinson's.

  • Surgical capabilities and MRI-guided deliveries
  • Dosing routes, including intrathecal, stereotactic
  • Experience in nonhuman primate and rodent models. Validation of rodents, including juvenile mice/brain space (intricate dosing success to get into brain spaces required)
  • Specialized pathology with neuro matter, including specialized staining and sectioning
  • Wide range of neurotoxicity assessments: anti-convulsant (PTZ), anti-convulsant (ECS), head twitch response test (5 HT2A antagonism), staircase model, tail flick, Randal-Selitto, hot plate, behavioral testing, electroencephalogram (EEG), learning and memory assessment, seizure liability, nerve conductance test, EthoVision™
  • Abuse liability testing of neurologically active products

Ophthalmology

Advance your ophthalmic program with world-class science, specialized technology and vision-related capabilities in ocular pharmacology, DMPK and safety studies. We can support your program across all drug and therapy classes. 

  • Diverse experience in multiple indications, anterior and posterior segments, rare ocular diseases, cell and gene therapies, and ophthalmic devices
  • Expert ophthalmology, imaging and electrophysiology support by the specialists of Ocular Services on Demand (OSOD), including bespoke consultations for dosing, reading, specialized exams and advice for designing studies to assess ocular-specific program and endpoints
  • Specialized ocular models, including rabbit, nonhuman primate, Göttingen minipig
  • Multiple routes of ocular dosing services: intravitreal, intracameral, etc.
  • Specialized equipment for anatomical and functional evaluation of your endpoints, such as tonometry, pneumotonometer, pachymetry, fundus photography, fluorescein angiograph, optical coherence tomography
  • Experience in cell and gene therapy-related ocular development
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respiratory

Respiratory 

For those pursuing a treatment compound or device for respiratory and lung diseases such as asthma, chronic obstructive pulmonary disease (COPD), lung cancers, cystic fibrosis (CF) or idiopathic pulmonary fibrosis, we offer pharmacodynamic models, respiratory pharmacologists specializing in lung function and an aerosol technology team for inhaled drug delivery. 

  • Multiple small animal models validated with clinically relevant positive control, plus bespoke model development upon request
  • Invasive (flexiVent, forced maneuvers) and noninvasive (plethysmography) lung function testing
  • Comprehensive local and systemic biomarker endpoints, including cytokine multiplexing and single-plate ELISAs, flow cytometry and other plate-based assays
  • AAALAC-accredited ABSL2 containment facilities to support pathogen (bacterial, fungal and viral) work
  • Inhalation delivery of cell and gene therapies

Rare diseases

Approximately 4% of people are affected by one of roughly 6,000 rare diseases. The majority are children, with more than 70% of genetic causality. Today, therapeutic advancements to treat and even cure rare diseases include oligonucleotides, RNA interference, viral, lipid nanoparticle packaged and transported gene replacement, gene editing, cell/stem cell therapies, and many more treatment modalities.

For 25 years, Labcorp has assisted in the development of therapies serving rare disease patients. Because the development of each therapeutic is a journey as unique as each rare population, we begin with a custom conversation that brings together your team with our knowledgeable therapeutic development specialists.

  • Advanced routes of administration in various in vitro and in vivo models and using divergent analytical techniques from those of traditional therapies
  • Over 20 years of experience delivering success with advanced therapies
  • Dedicated advanced therapy and AAALAC-accredited facilities for immunocompetent and immunosuppressed models
  • Surgical, ocular, CNS or inhalation capabilities depending on route/disease
  • Special study types, dose routes, in vivo models, report writing, SEND datasets and regulatory representation
  • Proven industry thought leadership, knowledge and programmatic success illustrated in many peer-reviewed publications, podium presentations and webinars

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