Join us on April 22nd for an exclusive webinar on #CGT development! Gain expert knowledge on optimizing #plasmid and #LVV production timelines, ensuring regulatory compliance, and navigating IND and BLA applications across global agencies. Don't miss this opportunity to stay ahead in the evolving CGT landscape!
Topic 1
Plasmid Applications and Production Challenges in Cell and Gene Therapy
Luffy Chen, Head of Plasmid PD and Production Dept., ProBio
- Plasmid applications in cell and gene therapy
- Develop new process to shorten plasmid production timeline and cut cost
- Understand how the industry is changing and where the challenges and opportunities are for the sector
Topic 2
Lessons from IND Clearances in CAR-T Development: From LVV Process Development to IND
Yucheng Lu, Sr. Scientist, Virus Manufacturing Dept., ProBio
- Performance of different LVV packaging systems
- Process optimization and scaling up
- Tech transfer and change control strategy
- Case sharing
Topic 3
CMC Regulatory Considerations for CGT Products
Tina Yu, Sr. Director of Regulatory Affairs Dept., ProBio
- Key principles in CGT development
- CMC considerations for IND application: ensuring safety and consistent quality
- Comparing IND review practices: FDA vs. NMPA
- Work scope for BLA application
Don't miss this opportunity!
Register now
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Jessica Tu
Regional Marketing Manager
ProBio
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