Webinar Alert! Building Robust Potency Assays with In-Cell Western Assay Protein Expression Readouts Register Today!

Histopathology Services Capabilities

PROVEN INTELLIGENCE ACCELERATING NEXT-GENERATION THERAPIES.

Histopathology Services Capabilities

High-Resolution Pathology Expertise for Advanced Modalities.

CELL & GENE | RNA | BIOLOGICS

Histopathology Services for Advanced Therapeutics

Definitive tissue-based analysis is fundamental to de-risking novel advanced therapeutics and complex biologics. Our approach applies proven intelligence in histology and histopathology to provide the tissue-level evidence required for successful regulatory submissions.

A close-up, blue-toned image of scientific glassware, featuring vials placed in a dish filled with clear, spherical beads, suggesting a laboratory or research setting.

A scientist in a modern lab analyzes colorful DNA sequencing data on a tablet.

Histopathological Characterization of AAV-Mediated Toxicities

While successful clinical outcomes rely on effective vector delivery, the clinical translation of AAV-mediated gene transfer is equally dependent on rigorous safety profiling. Foundational meta-analyses of Non-Human Primate (NHP) models demonstrate that AAV administration can lead to complex vector-induced toxicities, such as dorsal root ganglion (DRG) pathology (PMID: 32845779). These critical findings underscore the absolute necessity of advanced histopathological analysis to detect and characterize subtle toxicological events, such as mononuclear cell infiltrates and neuronal degeneration, ensuring that potential safety liabilities are definitively identified and de-risked prior to IND submission.

Integrated Platform for GLP and Non-GLP Studies

Our integrated platform provides the full spectrum of histological endpoints for both non-GLP discovery and GLP-compliant IND-enabling toxicology studies. All services are conducted within our 100,000 square-foot facility, ensuring data integrity and streamlined workflows from tissue collection to final report.

A close-up of a multi-channel pipette dispensing liquid into a microplate in a laboratory setting, with a blue color overlay.

Core Methodologies and Analytical Services

Our capabilities include:

  • Necropsy and Tissue Collection: Customized necropsies tailored to specific study requirements, including comprehensive tissue collection across rodent and large animal models.
  • Tissue Processing and Sectioning: Expert grossing and processing into formalin-fixed, paraffin-embedded (FFPE) or OCT-embedded frozen blocks, followed by precision microtomy.
  • Routine and Special Stains: A comprehensive library of stains including Hematoxylin and Eosin (H&E), Masson’s Trichrome, Sirius Red, Oil Red O, Luxol Fast Blue, and Periodic Acid-Schiff (PAS) to assess tissue morphology and pathology.
  • Immunohistochemistry (IHC) and Immunofluorescence (IF): Development and qualification of customized single- and multi-plex antibody panels to identify specific cell populations and protein expression.
  • In Situ Hybridization (ISH): Quantitative evaluation of RNA and DNA targets using validated platforms like Advanced Cell Diagnostics (ACD) to confirm transfection, transgene expression, and vector genome localization.
  • Digital Pathology: High-resolution whole-slide imaging and quantitative image analysis to provide objective, scalable data for pathology review.
Scientific Process Diagram

This content is for informational purposes. For guidance specific to your therapeutic program, please contact our team for a consultation.

Explore More Capabilities