随着生物制剂领域的持续快速发展，掌握监管路径、工艺开发和技术转移已成为成功的关键。通过本次网络研讨会，您将获得蓬勃生物专家的深度分享，助力推动创新、应对挑战。我们将提供实用策略，助您在生物制剂开发之路上迈向更高成就。
蓬勃生物诚邀您加入我们即将举办的网络研讨会， 深入探索监管路径、工艺开发和技术转移的实用策略！
会议时间
2025年4月8日 14:00-16:30 (GMT+8)
演讲者
Dr.Yu, Dr. Li, Dr. Jin
CMC Regulatory Consideration on Biologics Development
Topic 1 Abstract:
1
Overview of pharmaceutical regulatory systems (US & EU)
2
CMC regulatory considerations for Phase I clinical trials
3
Changes management during clinical trials
4
CMC work scope for the late-stage development (BLA/MAA)
5
Case study on regulatory life-cycle management for a new drug
Dr. Yu
Challenges and Solutions for Complex Biologics CMC
Topic 2 Abstract:
Discuss cell line, cell culture and purification development strategy for the following key challenges in CMC:
1
Product expression improvement
2
Homodimer control and removal
3
Aggregate control and removal
4
N-Glycan optimization
Dr. Li
Enhancing Technology Transfer: Strategies, Challenges, and Best Practices
Topic 3 Abstract:
1
Effective approaches to tech transfer
2
Key challenges and pain points in tech transfer
3
Case studies sharing
4
Tech transfer in PPQ
Dr. Jin
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2025-06-15
26页
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