Victorian Life Sciences

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

27-03-2025 03:57 PM

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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