Biologics

Most biologics are complex mixtures that are not easily identified or characterized. As a result, biologics are more challenging to manufacture, store, distribute, and deliver through traditional drug delivery routes.  Exponent has multi-disciplinary expertise in biologics used with medical devices and pharmaceuticals. 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 development process of biologics and the development of the associated containers/closures and delivery systems, including pre-clinical development and assays, manufacturing, and quality assurance.

Services

Specific capabilities include:


  • Development 
    • User research and needs identification
    • Requirements definition and Hazard Analysis
    • System concept prototyping and evaluation
    • 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 
    • Formative and summative user studies to support product development and submissions
    • Usability and Design History File Development
    • Assessment/qualification of third party devices for the delivery of the biologics
    • Enabling pre-clinical work through development engineering data collection systems
    • Supporting clinical trials through engineering measurement system development and validation
    • Review/analysis of the collected pre-clinical/clinical engineering data for Risk Management processes, as well as identification of development/differentiation opportunities
    • Manufacturing process scale-up / scale-down engineering support
    • Manufacturing process development for biologics/device assembly, packaging and sterilization
  • Quality assurance  
  • Cytotoxicity assays 
  • Biologic and biomaterial degradation profiling 
  • Purity 

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,  device development/evaluation support, packaging troubleshooting, failure analysis, clinical environment data acquisition, and data analytics.

Professionals