CBSET

Extensive Experience in the Evaluation of Medical Devices

Our expertise ranges from early device iteration, optimization, and mechanistic studies aimed at driving differentiation in the marketplace, to large-scale GLP safety assessments for regulatory submissions.

State-of-the-art medical device testing

We profile the safety and efficacy of implanted devices and combination products, and develop novel testing and assessment procedures with multiple regulatory compliances.

• Open paradigm of collaboration as a non-profit (501(c)(3)) institute
• Operational compliance and accreditation - GLP, OLAW, AAALAC
• Animal sciences expertise - full-time ACLAM-certified DVMs
• Experts in safety - full-time boarded DACVPs
• Full histology suite for all phases of embedding, sectioning, staining and imaging
• Customizable mechanical testing of both biomaterials and biological tissues
• Leaders in computational modeling of combination drug and energy delivery devices

Fully-equipped operating suites

We enable complex surgical procedures in our state-of-the-art facilities.

• Extensive surgical expertise in small and large animal models
• Multiple, fully-equipped ORs with anesthesia machines, ventilators, hemodynamic and airway gas monitoring systems
• Multiple surgery tables and hospital-grade fluoroscopy systems, including dedicated prep and recovery rooms for each suite
• Catheterization lab
• Adjoining conference facilities with 2-way video and audio

GLP-compliant imaging modalities

• Laparoscopic/Endoscopic Olympus towers
• OEC® Digital Fluoroscopy
• GE Innova System/3-D Angiography
• Computed Tomography (CT) and Optical Coherence Tomography (OCT)
• EP Mapping and Electrophysiology
• Ultrasound in a wide range of clinical applications, including Intravascular (IVUS), Transthoracic (TTE), Trans-esophageal (TEE), and Intra-cardiac (ICE) procedures
• Faxitron: Bench-top x-ray enables high resolution imaging of specimens and devices ex vivo
• Scanning Electron Microscopy (SEM)

Integrate lab animal sciences with physical modeling and pathology...

CBSET's multi-disciplinary approach can integrate computational modeling of drug release, absorption, and local tissue distribution. We pair the complexities of anatomic and surgical methods with a deep understanding of drug kinetics to meet your needs in a variety of applications, including:

• Pharmacokinetics (PK) / bio-distribution
• Drug-material interactions and formulation
• Computational and 3D modeling
• Controlled-release therapeutics
• Combination drug-device products

Integrate lab animal sciences with physical modeling and pathology...

CBSET's multi-disciplinary approach can integrate computational modeling of drug release, absorption, and local tissue distribution. We pair the complexities of anatomic and surgical methods with a deep understanding of drug kinetics to meet your needs in a variety of applications, including:

• Pharmacokinetics (PK) / bio-distribution
• Drug-material interactions and formulation
• Computational and 3D modeling
• Controlled-release therapeutics
• Combination drug-device products

Integrate lab animal sciences with physical modeling and pathology...

CBSET's multi-disciplinary approach can integrate computational modeling of drug release, absorption, and local tissue distribution. We pair the complexities of anatomic and surgical methods with a deep understanding of drug kinetics to meet your needs in a variety of applications, including:

• Pharmacokinetics (PK) / bio-distribution
• Drug-material interactions and formulation
• Computational and 3D modeling
• Controlled-release therapeutics
• Combination drug-device products

Supporting the Research Continuum, from Pilot to Regulatory Submission

As a multidisciplinary not-for-profit research institute, CBSET supports a range of applications in therapeutic and device development, with AAALAC-accredited animal research facilities and GLP-compliant analyses. Histology is a critical endpoint for the non-clinical evaluation of medical devices, drugs, biologics and biomaterials.

CBSET’s Comprehensive Histopathology Suite

Our histopathology suite and ACVP boarded pathologists provide flexible support and active collaboration for all facets of sample processing, staining, imaging and analysis, pairing it with expert interpretation and reporting. We will devise the right histopathology protocol for your aims and apply the optimal staining paradigm to satisfy your scientific endpoints.

Integrate lab animal sciences with physical modeling and pathology...

CBSET's multi-disciplinary approach can integrate computational modeling of drug release, absorption, and local tissue distribution. We pair the complexities of anatomic and surgical methods with a deep understanding of drug kinetics to meet your needs in a variety of applications, including:

• Pharmacokinetics (PK) / bio-distribution
• Drug-material interactions and formulation
• Computational and 3D modeling
• Controlled-release therapeutics
• Combination drug-device products

Staining Paradigms Selected to Elucidate Disease, Injury or Toxic Effect in Tissue

Primary staining provides rapid, low-cost visualization of any tissue type for robust qualitative assessments of histological changes. Common primary stain paradigms include:

• Cytology – e.g., Wright-Giemsa
• Histology
  • Fibrosis/ repair – e.g., Masson’s trichrome
  • Bone/ collagen – e.g., von Kossa, Goldner’s trichrome, safranin O
  • Vascular – e.g., Movat’s pentachrome, van Gieson elastin

Secondary staining (IHC, IFA, ISH) is used for pinpoint contrast and quantitative analysis. Immunohistochemistry (IHC) and Immunofluorescence (IFA) use antibodies targeting cellular biomarkers, coupled to chromogenic enzymes or fluorophores, for improved dynamic range and sensitivity. In Situ Hybridization (ISH) detects expression of RNA in sections via oligonucleotide hybridization to target RNA sequences.

• Neurologic – e.g., neurofilament (NF), tyrosine hydroxylase (TH), calcitonin gene related peptide (CGRP)
• Connective tissue/vascular – e.g., collagen I, collagen III, von Willebrand factor, actin
• Inflammation – e.g., CD3, CD79a, C18, CD68
• Cell death and proliferation – e.g., TUNEL, proliferating cell nuclear antigen (PCNA)
• Gene expression (custom oligonucleotide probes directed to mRNA targets)

Tissue biomarker analysis can include:

• Method development
• Secondary probe strategies for optimized signal detection and amplification
• A wide range of fluorophores, or fluorophore-conjugated secondary antibodies
• Multiplexing for simultaneous visualization of multiple markers
• Quantitative analysis/ scoring of localization and intensity of signals

CBSET’s Comprehensive Histopathology Suite

Our histopathology suite and ACVP boarded pathologists provide flexible support and active collaboration for all facets of sample processing, staining, imaging and analysis, pairing it with expert interpretation and reporting. We will devise the right histopathology protocol for your aims and apply the optimal staining paradigm to satisfy your scientific endpoints.

Slide preparation capabilities include:

• Tissue trimming and fixation
• Paraffin and plastic resin processing
• Embedding, sectioning and staining
• Microtomy and EXAKT micro-grinding

Tissue Preparation Services

Tissue Processing Services

Biospecimens Services

Clinical and Anatomic Pathology Services

Clinical Laboratory Services

Clinical Research Services

Biomarkers Services

Bioanalysis Services

Pharmacology Services

Pharmacology & Toxicology Services

Drug Discovery & Development Services

ADME/DMPK Studies Services

In vivo ADME/DMPK Studies Services

Formulation Services

Medical Devices & Diagnostics Services