质粒和病毒载体在细胞与基因治疗（CGT）中发挥着关键作用。然而，从临床前研究到商业化生产的不同阶段，其应用和生产面临诸多挑战，包括如何优化工艺、提升效率，并确保符合全球监管要求，以顺利推进IND和BLA申报。

本次研讨会将汇聚行业专家，深入剖析质粒与慢病毒载体（LVV）的生产优化策略，解读最新监管考量，助力企业加速产品开发与申报进程。

蓬勃生物诚邀您参加即将举办的网络研讨会，共同探讨关键工艺优化策略与监管合规要点！

2025年4月22日 14:00-16:30 (GMT+8)

Dr. Chen, Dr. Lu and Dr. Yu

Plasmid Applications and Production Challenges in Cell and Gene Therapy

• 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

Dr. Chen

Lessons from IND Clearances in CAR-T Development: From LVV Process Development to IND

• Performance of different LVV packaging systems

• Process optimization and scaling up

• Tech transfer and change control strategy

• Case sharing

Dr. Lu

CMC Regulatory Considerations for CGT Products

• 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

Dr. Yu