Roundtable Discussion: An Industry-Wide Opportunity to Benchmark & Knowledge Share on Critical Quality Testing & Regulatory Considerations Associated with Establishing Master Cell Banks (MCBs) & Working Cell Banks (WCBs) to Ultimately Improve Efficiency &
Time: 2:00 pm
day: Conference Day 1
Details:
- What kinds of challenges (analytical, regulatory, etc.) are typically faced when looking to qualify a certain type of cell line?
- What considerations are deemed important when establishing MCB or WCB? What was the end goal of this cell bank?
- What kind of release testing should be performed to release the cell bank for use and why did?
- What kind of stability programs should be implemented for the MCB? What kind of analytical testing should be carried out?
