Mastering BLA Readiness: Advanced Process Characterization for Robust and Accelerated Process Validation and Biologics Commercialization

In the race to bring biologics to market, achieving BLA success demands speed—and more than that, it requires precision, foresight, and a deep understanding of BLA data. This webinar unveils how WuXi Biologics leverages cutting-edge process characterization strategies to accelerate timelines, ensure compliance, and derisk commercialization.

Register Free: https://www.biopharminternational.com/bp/biologics-commercialization

Event Overview:

Time is critical, but shortcuts in process characterization risk costly delays and regulatory setbacks. In this webinar, WuXi Biologics—a global leader in end-to-end biologics development—reveals an advanced process characterization platform. The platform combines modular workflows, risk assessment frameworks, fit-for-purpose design and data analytics, and deep regulatory expertise to turn BLA preparation into a strategic advantage.

Learning Objective:

• Speed without compromise: Learn how integrated Quality by Design frameworks and high-throughput methods reduce process characterization timelines while maintaining regulatory rigor.
• Robustness by design: Discover advanced design of experiments and multivariate analysis techniques that build a robust process control strategy to guide long-term commercial consistency.
• BLA success: Explore real-world case studies demonstrating WuXi Biologic’s ability to streamline process characterization and validation, address CMC challenges, and secure regulatory approvals.

Who Should Attend:

• Process development scientists and engineers
• CMC leads and experts
• Manufacturing science personnel
• Consultants

Speaker:

Ying Hou, Ph.D
Director in Manufacturing Science and Technology Department
WuXi Biologics

Dr. Ying Hou holds a Ph.D. in Biopharmaceuticals from Jiangnan University in China. With over ten years of experience at WuXi Biologics, she has extensive expertise in upstream process development. Dr. Hou has led more than 30 projects spanning early and late-phase development, process characterization, and process validation (PPQ) campaigns. She has also provided critical support for commercial manufacturing processes, ensuring robust and scalable therapeutic production.

Register Free: https://www.biopharminternational.com/bp/biologics-commercialization