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Webinar - From DNA to Therapy: Exploring Plasmid Applications, LVV Manufacturing, and Regulatory Insights

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Join us on April 22ⁿᵈ for an exclusive webinar on Cell and Gene Therapy (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!

Luffy-Chen
Luffy Chen
Head of Plasmid PD and Production Dept., ProBio
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Yucheng Lu
Sr. Scientist Virus Manufacturing Dept., ProBio
Speaker_Derek_Chen-2026
Tina Yu

Sr. Director

Regulatory Affairs Dept., ProBio

Time
Topic
14:00-14:45
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
14:45-15:30
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
15:30-16:15
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