A 101 in Potency Assays
Time: 8:30 am - 10:30 am
day: Pre-Conference Workshop Day
Details:
- Establishing potency assays relevant for your therapeutic activity
- Developing potency measurements that reflect the product’s mechanism of action
- How early should potency assay development begin?
- How should you adapt your matrix approach through early- to late-stage development?
- Recommendations for assay design and validation, including the importance of using reference materials and standards
- Dissecting the new FDA guidance on potency assurance: how should these be interpreted and implemented to guide strategy?
- Discussing real-life case studies of potency strategies used to support IND filings
