Medical Devices

Product Characterization and Reference Standards

Understanding your product is of paramount importance. Regulators require it, investors demand it, and it can mean the world to your patients. Getting this testing right is critical throughout the development cycle. We have helped clients on a number of important projects, including:

  • Development, oversight, and review of protocols and assessments related to the product characterization efforts, including experimental design and data analysis
  • Characterization work related to product comparability after scale and process changes
    • Selection of appropriate comparability methods and techniques
    • Assessing the significance of differences that will be found
    • Designing comparison experiments to maximize insight into real differences vs method variability
  • Development of strategy for identifying and producing appropriate reference standard
    • Assignment of critical certification parameters such as strength and potency
    • Selection of appropriate presentation/configuration to maintain critical properties
    • Bridging between different batches of standard
  • Development of strategy for long-term management of the reference standard and other critical reagents
  • Composing and reviewing protocols for characterizing the reference standard