Selection of Reference Standard for Release Assays for Cell & Gene Therapeutics

Time: 12:30 pm
day: Day One


  • Reviewing USP reference standards. What does the US pharmacopeia recommends in the Pharmaceutical industry?
  • Exploring product-specific standards selection and considerations for each assay.
    • When to start the production of your own reference material?
    • How stringent do you want to be?
    • How to accommodate the RS to the possible changes from initial product development to commercial product?
  • From fit for purpose to qualification. When to qualify your standard materials?