Jose Caraballo
Vice President Quality: Compliance, Quality Systems, and Quality Engineering Kite Pharma Inc
Seminars
Wednesday 16th September 2026
Panel Discussion: Designing Commercial Manufacturing for Speed or Scale & the Regulatory Trade-Offs
3:00 pm
- Debating whether commercial manufacturing should prioritize commercial scalability from day one or focus on the fastest path into the clinic, and how each choice shapes regulatory strategy
- Examining how early process design and analytical development decisions impact potential CMC approval for commercial studies
Tuesday 15th September 2026
Automating CAR-T Manufacturing: Governance, Validation & Readiness for Commercial Scale
11:30 am
- Evaluating where automation delivers the greatest operational value in CAR-T manufacturing processes
- Integrating automated platforms within GMP manufacturing and quality systems while maintaining data integrity and oversight
- Establishing governance and validation strategies to ensure reliability and regulatory readiness as manufacturing scale
