Comprehensive Research Services | Innovating Preclinical Drug Development

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.

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.

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.

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.

				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

  	

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