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Program Value, Delivered.

From preclinical proof of concept to large-scale IND-enabling safety studies, we provide actionable data.

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Research Solutions

Biomedical funding realignments have demanded capital efficient paths to clinical data. 

As scientists, our aim is to guide you through the design and execution of preclinical studies that will drive value to your program. As a development partner, our responsibility is to help you efficiently allocate capital to drive stakeholder return—the patients in need, and the investors supporting your vision and strategy to bring treatments to market.

To inform investment decision making, we have established a no-risk engagement model where we design studies and furnish budgets at no-cost to you, allowing for accurate project planning.

For efficient and cost effective scientific execution we combine preclinical and clinical therapeutic area expertise with advanced nonhuman primate (NHP) translational R&D capabilities, and tightly integrated histopathology and molecular research cores.  This provides turn-key scientific engagement, study execution, sample processing, data analysis, and study reporting.

This “platform” approach is underpinned by our unique, cost-effective access to nonhuman primates that conveys significant time and cost savings and data delivery to improve development outcomes.

From Strategy to Execution

Align your preclinical strategy, study execution, and endpoint analysis with the decisions that move development forward.
Contact Us Today

NHP Research Services

Our mission is to bring clarity and confidence to R&D investment decisions through an efficient request for proposal process and delivery of high value, clinically relevant models and preclinical services.

Virscio drives accurate characterization of human risk and response to intervention to speed candidate selection and improve clinical success. Subject selection, model optimization and well characterized quantitative endpoints further allow reduction and refinement of animal use. Our integrated in vivo, histopathology, and molecular research cores combined with unparalleled, ready access to a biologically clean primate population permits screening and recruitment of treatment naïve or non-naïve animals of preferred age range (neonate to geriatric), sex, weight and number, guided by specific research objectives.

We fully support critical development stages, spanning in silico homology diligence, preclinical strategy, protocol design, in-life study execution, sample processing, data analysis, study reporting and defining regulatory path, with a focus on in vivo primate efficacy and safety, pharmacokinetics, pharmacodynamics and therapeutic delivery.

Preclinical Study Types

  • Pharmacokinetics (PK)
  • Pharmacodynamics (PD)
  • Drug Delivery & Route of Aministration
  • Safety Pharmacology
  • GLP Toxicology (Acute & Chronic)

Therapeutic Area Expertise

  • Central nervous system
  • Ophthalmology
  • Cardiovascular
  • Metabolic
  • Immunology
  • Oncology
  • Renal / Urinary
  • Gastrointestinal
  • Respiratory
  • Aging

Modality Expertise

  • Small molecules
  • Monoclonal antibodies
  • Antibody drug conjugates (ADCs)
  • Antisense oligonucleotides (ASOs)
  • RNA (RNAi, mRNA, etc.)
  • Exosomes
  • Liposomes
  • Adeno-associated virus vectors (AAVs)
  • Lentivirus vectors
  • Cell therapies
  • Vaccines

Routes of Administration

Systemic

  • Oral

  • Subcutaneous

  • Intramuscular

  • Intravenous 

  • Transdermal

  • Nasal

Central Nervous System

  • Intraventricular

  • Intrathecal

  • Intraparenchymal

  • Subpial 

Ophthalmic

  • Intravitreal

  • Subretinal

  • Intracameral

  • Topical

  • Punctal

 

Surgical Procedures

  • Neurosurgical
  • Ophthalmic
  • Cardiac
  • Renal
  • Orthopedic
  • Stereotaxic
  • MRI-guided
  • Telemetry
  • Device implantation

Sample Collection

  • Serum
  • Plasma
  • Whole blood
  • PBMC
  • Cerebrospinal fluid
  • Urine
  • Aqueous humor
  • Vitreous humor
  • Tissue biopsies
  • Tissue dissociation for single cell RNA-Seq
  • Tissue fixation
  • Comprehensive tissue collection

Compliance

Virscio maintains an acclaimed animal program consistently meeting the highest AAALAC and OLAW standards and aligned to USDA and European animal welfare regulatory guidance. Virscio operates under FDA good laboratory practice (GLP) and supports preclinical studies conducted for regulatory submission in compliance with OECD GLPs.

NHP Disease Models

Virscio has established a range of nonhuman primate models that emulate human disease pathology to support efficacy evaluations of small molecules, biologics, gene and cell therapies, medical devices and delivery technologies.

All models must meet the following critical induction, characterization, and validation criteria before being employed in sponsor-funded screening studies:

  • The clinically relevant disease pathology can be reproducibly induced within variability limits that allow candidate screening protocols of sufficient statistical power to permit discovery and development decisions.

  • The induced disease pathology can be modulated by a clinical standard of care intervention and/or the therapeutic target is present in the induced disease phenotype and can be measured or inferred through validated, correlated endpoints.

  • The disease pathophysiology can be induced and sustained with limited animal welfare impact.

Ophthalmology Models  

  • Wet age-related macular degeneration
  • Retinal neovascularization
  • Retinal epithelium and photoreceptor degeneration
  • Glaucoma
  • Uveitis
  • Optic neuropathy
  • Mitochondrial dysfunction
  • Surgical inflammation
  • Myopia
  • Amblyopia
  • Cataract

Central Nervous System Models

  • Alzheimer’s disease
  • Parkinson’s disease
  • Stroke
  • Spinal cord injury
  • Schizophrenia
  • Dystonia
  • Behavior and cognition

Cardiovascular Models

  • Hypertension
  • Heart failure
  • Chronotropic and inotropic effects

Metabolism Models

  • Diet-induced obesity
  • Hyperlipidemia
  • Body composition
  • Energy expenditure

Discover more about our modeling capabilities

Visit our science library to access  resources describing Virscio’s translational research capabilities, including posters, model overviews, journal articles and more.

Visit Our Science Library

Digital Histopathology Services

Virscio’s digital histopathology and histomolecular core fully supports all tissues types and species, ranging from mouse to nonhuman primate and human.  

Quantitative assessment of critical safety and tissue pharmacodynamic endpoints are achieved through precision tissue processing, robust assay validation, image analysis, and integration of orthogonal data.

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Discovery Histopathology

  • Target distribution and indication selection
  • Tissue distribution of AAVs, EVs,  lipid nanoparticles, other viral and non-viral vectors, stem cells, therapeutic antibodies, tag proteins (GFP, RFPs, FLAG, V5, HA)
  • Rigorous immunohistochemistry assays development using 20+ tissue matrices correlated with single cell RNA-Seq and public omic databases
  • Model characterization, validation and efficacy assessment referencing established historical control databases

Toxicologic Histopathology

  • Non-GLP and GLP nonclinical safety primary interpretation and peer-reviews in African green monkey, cynomolgus monkey, mouse, rat, dog, pig, human, and other test systems
  • Mechanistic toxicology, including companion molecular methods (RNA-Seq, western blot, qRT-PCR, ELISA)
  • Briefing books and IND authoring, representations at Type C meetings, and responses to FDA comments

Histopathology Tools

  • Specialty and customized trimming of complex tissues (e.g., eye, kidney, heart, brain)
  • Processing to paraffin and frozen sections
  • Extended catalog of special stains 
  • Whole mount immunohistochemistry (IHC)
  • Extended catalog of optimized immunohistochemistry assays
  • In situ hybridization
  • Multiplex IHC
  • Duplex IHC/ISH
  • Duplex ISH
  • Visiopharm image analysis with AI app development 
  • Secured digital histology platform (Concentriq for Research)
  • Data integration of clinical pathology, circulating and tissue biomarkers, omics, and in vivo readouts
  • Custom tissue microarray assembly including cell pellets and tissues
  • Western blots, ELISA, qRT-PCR
  • Nonhuman primate tissues of diverse age with and without test article exposure
  • In-house quality assurance unit (QAU) supports GLP studies accommodating .svs, .mrxs, .ndpi, and other Visiopharm supported file formats
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Multiplex IHC

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Duplex IHC/ISH

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Duplex ISH

Have questions about our histopathology platform?

We are ready to solve your translational need and accelerate your path to clinical success.
Contact Us Today

Molecular Biology

Virscio’s molecular biology services provide mechanistic insights into disease model pathophysiology and the tissue pharmacodynamics of interventions in in vivo and ex vivo experiments in primate and non-primate test systems.
Custom method development and validation
  • Bespoke method and test system development and validation to achieve data objectives building on portfolio of established assays
  • Analysis of all tissue types, including liver, spleen, kidney, brain, eye, and difficult to process organs
High-throughput tissue sample processing
  • DNA, RNA and protein isolation from tissue, blood, biofluids and cultured cells
  • Isolation and quantification using Agilent 2100, Spectra Max, Qubit, and Nanodrop
Biodistribution assays
  • Custom biodistribution assay development for multiple tissues, including heart, liver, brain, and eye
  • Sample analysis using qPCR and ddPCR for WPRE, ITR2, GAPDH, TERT, GFP, Beta-ACTIN
ELISA assays

  • Validation of custom or commercially available ELISA assays and sample analysis 

Primary cell isolation
  • Isolation of PBMCs, hepatocytes, fibroblasts and other cell types
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Gene expression profiling
  • Comprehensive DNA and RNA quantification, quality assessment
    and stability analysis
  • Expression profiling for study specific genes and genes of common interest (e.g., LIF, LEPTIN, CNTF, IL6, GFAP, C3, VIMENTIN, RLBP1, FGF2, EDN2, TNF)
  • Absolute and relative quantification through qPCR and ddPCR 
  • Bulk RNA-Seq
  • Single cell sequencing
Western blots
  • Method development, assay validation, and high throughput analysis for study specific proteins and proteins of common interest (e.g., MAPT, NEFL, GFAP, VIMENTIN, TUBULIN, C3, and Beta-ACTIN)
Tissue dissociation and library preparation for single cell sequencing
  • Single cell dissociation and library preparation for PBMC, CNS, retinal and other cell types for Parse and 10x Genomics sequencing protocols
Data capture and reporting
  • Robust program management and electronic data capture to meet documentation, regulatory, and timeline needs

Have questions about our molecular research capabilities?

We are ready to solve your translational need and accelerate your path to clinical success.
Contact Us Today

Third Party Collaborators & CRO Partners

Virscio regularly works with qualified specialty laboratories and consultants to execute elements of the research plan not conducted directly by Virscio. Site or consultant qualification is performed by Virscio’s senior scientists and quality assurance unit, and clients benefit from our network of established research service providers, spanning bioanalysis to regulatory guidance.

Specimen shipment for analysis at third party or sponsor laboratories is achieved through a well-established, temperature-controlled chain of custody with full tracking and logistical support from Virscio to recipient.

VIRSCIO RESEARCH SERVICES

Frequently Asked Questions

What are the routes of administration that can be evaluated in the African green monkey?

What are the routes of administration that can be evaluated in the African green monkey?

Anatomy of the green monkey supports all commonly employed clinical routes of administration, as well as the refinement and characterization of achievable biodistribution through less common routes (e.g., intracerebroventricular, suprachoroidal, retrouretral, etc.).
What are the clinical endpoints that can be evaluated in the African green monkey?

What are the clinical endpoints that can be evaluated in the African green monkey?

Ocular and central nervous system anatomy enable the application of human clinical instrumentation for imaging and physiological measures, heightening correlation and relevance to human biomarkers. Organ and vascular anatomy enable non-terminal and terminal tissue sampling sufficient for multi-endpoint and multiomic analyses. Cognitive function enables conduct of neuromotor and cognitive testing requiring more sophisticated training paradigms.
What are the analytical endpoints that can be evaluated in the St. Kitts green monkey?

What are the analytical endpoints that can be evaluated in the St. Kitts green monkey?

An extensive library of antibodies has been validated for immunohistochemistry analyses of green monkey tissues, with broad conservation across humans and macaques. Likewise, many commercially available human ELISA kits or multiplex assays (e.g., Olink) have been confirmed compatible with green monkey analytes. The existing reference genome enables development of relevant primers and evaluation of gene and protein sequence homology.
What approaches are taken to establishing bridging studies and data to allow transitioning translational studies to the green monkey?

What approaches are taken to establishing bridging studies and data to allow transitioning translational studies to the green monkey?

Virscio routinely conducts bridging studies to evaluate whether initial understanding of a candidate evaluated in another nonhuman primate or non-primate test system translates to the green monkey. Such studies are designed to compare to prior in-life evaluations, while optimizing what can be enhanced such as administration method, dose range, or additional positive or negative controls. We value working with all existing data to best inform design and next translational steps.
What endpoints can be evaluated in St. Kitts?

What endpoints can be evaluated in St. Kitts?

At the St. Kitts testing facility there is full capacity to capture in-life behavioral, cognitive, neuromotor, electrophysiology and medical imaging data, and to analyze clinical pathology, and molecular endpoints. Histopathology, immunohistochemistry, in situ hybridization and additional protein assays are conducted at Virscio’s Connecticut laboratory.
What is the infectious disease response relative to other in vivo research models?

What is the infectious disease response relative to other in vivo research models?

The human-like response to infections such influenza, filoviruses, and SARS-CoV2 has favored use of the African green monkey for vaccine development and infectious disease prevention research over other nonhuman primates.

Translational research starts with selecting the right platform.

Connect with Virscio to discuss your research objectives and study strategy.