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Research Services

Virscio is a leading provider of nonhuman primate data and histomolecular services to effectively guide your programs and candidates to clinical success.

From preclinical proof of concept to IND-enabling GLP safety studies, Virscio’s goal is to bring clarity and confidence to R&D investment decision making and improve the odds of clinical translation.

We fully support critical development stages, spanning 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.

Virscio additionally performs advanced histopathology and molecular analysis in support of both primate and non-primate preclinical studies. Our capabilities are enabled by extensive experience.

Translational Experience

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... and globally distributed pharmaceutical, biotechnology and academic sponsors

Efficacy Models

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

Applied models meet these critical induction, characterization and validation criteria:

    • 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

Central Nervous System

Cardiovascular

Metabolism

Immunology

Delivery

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Our Research Solutions

Virscio’s unique, unparalleled access to a biologically clean primate population allows timely initiation of studies in treatment naïve or non-naïve animals of preferred age range, sex, weight and number, guided by specific research objectives. 

By employing clinically relevant primate models, Virscio drives accurate characterization of human risk and response to therapeutic candidates 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.

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Study Designs Conducted

Routes of Administration

Gene and Cell Therapy Evaluations

Sampling

Surgical Modeling

Safety Endpoints

Scheduling and Excecution

Discover more about our capabilities

Visit our scientific library and get access to a wide range of resources showcasing Virscio’s translational research capabilities, including posters, case studies, journal articles and more.

Visit Our Science Library

Histopathology

 Virscio’s histopathology and histomolecular experience fully supports both nonhuman primate studies and studies conducting in other non-primate species.  

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

We apply our expertise to help guide your histopathology strategy and objectives.

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Discovery Histopathology

  • Target distribution and indication selection
  • Tissue distribution of AAVs, 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 (RNASeq, 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 
  • Extended catalog of optimized immunohistochemistry assays
  • Whole mount immunohistochemistry (IHC)
  • 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 microarrays 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

Therapeutic Areas

  • Ophthalmology
  • Neurology
  • Cardiovascular
  • Immunology/inflammation
  • Metabolic
  • Oncology
  • Musculoskeletal
  • Renal/urinary
  • Gastrointestinal
  • Skin
  • Respiratory

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.

We work with you to develop molecular analysis strategies to optimize scientific and budgetary scope and objectives.

Custom method development and validation
  • Bespoke method and test system development and validation to achieve data objectives
  • Analysis of all tissue types, including liver, spleen, kidney, brain, eye, and difficult to process tissues
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 (LIF, LEPTIN, CNTF, IL6, GFAP, C3, VIMENTIN, RLBP1, FGF2, EDN2, TNF)
  • Absolute and relative quantification through qPCR and ddPCR 
Western blots
  • Method development, assay validation, and high throughput analysis for study specific proteins and proteins of common interest (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

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 commonly utilized 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. Musculoskeletal, 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 samples. 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 non-primate or nonhuman primate test system translates to the green monkey. Such studies are designed to match what is appropriate 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 the right platform.

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