Services and Capabilities

The goal of the THERAPEUTEX Preclinical Core Lab is to characterize properties of new therapeutic compounds in animal models by focusing on drug delivery and pharmacokinetic/pharmacodynamic (PK/PD) studies. Efforts include drug formulation and optimization of delivery method as well as development of various disease related animal models with expertise in infectious disease and cancer/angiogenesis, evaluation of optimal drug concentrations, toxicity, efficacy, and target validation by tissue analysis of drug accumulation, metabolism, and elimination.


 

Drug Formulation Characterization

THERAPEUTEX offers a variety of methods to characterize the physicochemical properties of pharmaceutical materials.  These techniques can be applied for pre-formulation, formulation, or device testing.  Inhaled formulation characterization is a specific area where THERAPEUTEX has extensive resources and a high level of expertise.

  • USP Dissolution
  • HPLC analysis
  • Geometric Particle Size Analysis (micron and submicron)
    -Inhalation Cell and Wet Sample Dispersion Unit
  • Aerodynamic Particle Size Analysis
  • Aerosol Dose Uniformity
  • Differential Scanning Calorimetry
  • Rheometry
  • Texture Analysis
  • Powder Flowability
  • Bulk, Tap, and True Density
  • Moisture Sorption
  • Powder Surface Energy Characterization
  • Atomic Force Microscopy

Preclinical and Proof-of-Concept Studies

The THERAPEUTEX Preclinical Core Lab can help transition compound studies to the next level of preclinical and proof-of-concept studies.  With faculty and staff expertise in pulmonary disease, cancer/angiogenesis, and infectious disease, the
THERAPEUTEX team can help with nearly all aspects of the study, including: experimental design and implementation, animal colony management and genotyping, surgical technique, and data analysis.

  • Rodent Vivarium with General Husbandry
  • Ectopic and Orthotopic Tumor Models
  • Rodent Drug Delivery
    -Routes include intravenous (tail vein, jugular cannulation), subcutaneous, intraperitoneal, intramuscular, oral gavage
    – Nose-only pulmonary dosing
  • Rodent Surgery and Blood Collection
  • Tumor 3D Histoculture
  • Cell Culture
    – Pulmonary and cancer cell lines
    – Viability, proliferation, and cytotoxicity assays
  • Microplate Photometer
  • Horizontal and Vertical Electrophoresis
  • Polymerase Chain Reaction
  • Western Blotting
  • Refrigerated Clinical Benchtop Centrifuge and Refrigerated MicroCentrifuge
  • Stereomicroscope System
    – Whole tissue/animal and live cell imaging with imaging software
  • Cryogenic Storage, Chromatography Refrigerator, Enzyme/Lab Freezer, Ulra Low Freezer

Lab-Scale Formulation Production

THERAPEUTEX also offers small scale formulation production for use in R&D studies.  Some of the production capabilities include the following:

  • Mechanical particle size reduction (ball milling, jet milling, high pressure homogenization, cryogenic)
  • Tableting
  • Lyophilization
  • pMDI packaging
  • Stability chambers

Histology Services

Once tissue and blood samples have been collected, several different forms of target validation by analysis of drug accumulation, metabolism, and elimination can be evaluated.

  • Tissue Processing
  • Paraffin and Glycol Methacrylate Embedding
  • Microtome and Cryotome Sectioning
  • Immunostaining (IHC and ICC) and Custom Staining
  • Inverted Fluorescent Microscope with Imaging Software

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