Exponent has multi-disciplinary expertise in biologics applied to the medical device and pharmaceutical arenas. We can characterize and assist in development of combination products that contain cells, scaffolds, and bioactive drug entities. We have experience in multiple state-of-the-art technologies that can be applied to all stages of the biological and pharmaceutical device development process, including pre-clinical development and assays, manufacturing, and quality assurance.
Specific capabilities include:
- Development
- Pre-clinical model development
- Cell culture within 2D and 3D environments
- Cell migration assays
Cell phenotype and response characterization
- Gene expression
- Tissue phenotype assessment
- Toxicity assessment
- Microfluidic and microscale systems development
- Biomaterials characterization
- Morphology, pore size, chemical composition, mechanics
- Assessment of biomaterial/tissue integration
- Assessment of impact of biologic/therapy on device or material
- Biophysical property measurements
- Assessment of drug delivery and penetration
- Quality assurance
- Cytotoxicity assays
- Biologic and biomaterial degradation profiling
- Purity
- Device performance
Our proficiencies in core technologies include microscopy (light, confocal, fluorescence, SEM), histology and immunohistochemistry, RT-PCR, digital imaging, materials and device mechanical testing, micro CT, spectroscopy and spectroscopic imaging (mid- and near-infrared and Raman), MRI, particle nanotechnology, and aerosol drug delivery systems.