What are some of the challenges associated with protein-based formulations?

  • Protein aggregation
    • Negative patient reaction
    • Impact efficacy of drug product
    • Homogenous & heterogeneous aggregates pose an issue
  • Handing can change the material
    • Pumping (shear force)
  • Protein-based products can be more sensitive to heat and light
  • Contamination from vials, containers, dispensing systems or other equipment that come into contact with the formulation