Key Considerations for Establishing a Working Cell Bank (WCB) as a Biological Raw Material for Release Testing & the Implementation into the Quality Target Product Profile (QTPP)
Time: 1:30 pm
day: Conference Day 1
Details:
- Developmental and functional testing strategies needed to determine the proper cellular target to use based on clinical data and clinical considerations. Product characterization testing for biological AMs
- Key regulatory considerations and USPs needed in establishing biological raw material release testing and the stability testing needed to prove efficiency and biological effect over a certain period of time
- What is a QTPP and how should one be structured?
- How and where the process of getting a Master Cell Bank (MCB) and WCB should begin based on the established QTPP?
