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