药明合联网络研讨会：以技术创新与一体化平台加速ADC后期开发至BLA
From Clinical to Commercial: Accelerating ADC Late-Stage Development With Technology Innovation and an Integrated Platform
药明合联（WuXi XDC）举办免费网络研讨会，介绍其中国与新加坡一体化全球生产平台如何加速ADC从临床开发走向商业化，覆盖抗体、连接子-载荷、原液、制剂、分析与法规能力。公司称其遵循FDA三阶段工艺验证框架，提供工艺设计、确认及PPQ准备，并掌握10余项偶联技术。演讲人为该公司美西地区CMC管理高级总监Lan Dai博士。
Fast-track your late-stage ADC to BLA with an integrated, global manufacturing partner.
Register Free: https://www.biopharminternational.com/bp_w/Clinical-to-Commercial
Event Overview:
Accelerate your antibody-drug conjugate (ADC) from clinical development to commercial success with WuXi XDC’s fully integrated, global manufacturing platform. The company’s strategically connected China and Singapore network brings antibody, linker-payload, drug substance, drug product, analytical, and regulatory expertise together—streamlining execution, shortening timelines, and strengthening supply resilience.
Guided by the US Food and Drug Administration’s 3-stage process validation framework, WuXi XDC delivers robust process design, rigorous qualification, and sustained lifecycle performance. Clients benefit from proven platforms, expertise across more than 10 conjugation technologies, scalable single-use facilities, risk-based characterization, robust control strategies, and comprehensive preparation for process performance qualification (PPQ).
Successful collaborations with biotech companies showcase WuXi XDC’s ability to combine quality, speed, agility, and commercial-scale execution. With WuXi XDC, innovators gain a trusted partner equipped to fast-track late-stage ADC programs toward a biologics license application and reliable global supply.
Key Learning Objectives:
- Understand ADC commercial momentum and key challenges shaping CMC readiness.
- Explore WuXi XDC’s late-stage capabilities and integrated supply infrastructure.
- Discover WuXi XDC’s strategies for late-stage product lifecycle management.
Who Should Attend:
- ADC development scientists
- CMC professionals
- Process development scientists
- Analytical development scientists
- Manufacturing scientists
- Pharmaceutical development managers
Speaker:
Lan Dai, PhD
Senior Director
WuXi XDC
Lan Dai, PhD, brings 15 years of biotechnology CMC experience, specializing in product quality control strategies for biologics from IND through BLA and post-approval lifecycle management, including ADCs, bispecifics, and monoclonal antibodies. Before joining WuXi XDC as senior director of CMC management for the US West region, she held technical leadership roles at Genentech, Exelixis, and other Bay Area companies. She completed postdoctoral research in bioconjugation at Pfizer after earning her PhD in bioinformatics from the University of Michigan, Ann Arbor.
Register Free: https://www.biopharminternational.com/bp_w/Clinical-to-Commercial
来源：BioPharm International · biopharminternational.com