Webinars » CGT » From DNA to Therapy: Exploring Plasmid Applications, LVV Manufacturing, and Regulatory Insights

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


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

  • Yucheng Lu

    Yucheng Lu
    Sr. Scientist
    Virus Manufacturing Dept., ProBio

  • Tina Yu

    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

Find more available materials

Related service: Plasmid manufacturing, LVV manufacturing