In this module, you will learn about reference standards used in conjunction with Ph. Eur. monographs and general chapters to ensure the quality of biologicals. It will cover the basis of their scientific establishment, provide additional information on their use and address questions that you may have as a user. Recent practical examples from both physicochemical and bioassay applications will illustrate the session.
Programme (subject to change):
- 14:30-15:00 Ph. Eur. reference standards for biotherapeutics: intended use in physico-chemical tests
- 15:00-15:45 Ph. Eur. Biological Reference Preparations (BRPs) for bioassays
- 15:45-16:00 Live Q&A (RS)