Webinar - Navigating Biologics Challenges：Regulatory, Process Development, and Tech Transfer Solutions As the biologics field rapidly evolves, mastering regulatory pathways, process development, and tech transfer is essential for success. Gain key insights to drive innovation and overcome challenges. This discussion will provide practical strategies to support your biologics development journey. Join our webinar on April 8th! Register Now Tina YuSr. Director Regulatory Affairs Dept., ProBio Ying LiDirectorAntibody R&D and Purification PD Dept., ProBio Xue JinSr. ScientistAntibody PD and MSAT Dept., ProBio Time Topic 14:00-14:45 CMC Regulatory Consideration on Biologics DevelopmentTina Yu, Sr. Director of Regulatory Affairs Dept., ProBio Overview of pharmaceutical regulatory systems CMC regulatory considerations for Phase I clinical trials Changes management during clinical trials CMC work scope for the late-stage development (BLA/MAA) Case study on regulatory life-cycle management for a new drug 14:45-15:30 Challenges and Solutions for Complex Biologics CMCYing Li, Director of Antibody R&D and Purification PD Dept., ProBioDiscuss cell line, cell culture and purification development strategy for the following key challenges in CMC: Product expression improvement Homodimer control and removal Aggregate control and removal N-Glycan optimization 15:30-16:15 Enhancing Technology Transfer: Strategies, Challenges, and Best PracticesXue Jin, Sr. Scientist of Antibody PD and MSAT Dept., ProBio Effective approaches to tech transfer Key challenges and pain points in tech transfer Case studies sharing Tech transfer in PPQ Find more available materials Related service: Cell Line Development, IND Enabling CMC, ProBoxTM Process Development Tool Box, GMP Manufacturing
Latest WebinarsNavigating Biologics Challenges：Regulatory, Process Development, and Tech Transfer SolutionsPre-clinical DMPK Study and Generation of Toolbox to Facilitate PK/ADA AnalysisMultiple Solutions of Functional Leads Discovery and EngineeringAntibody Engineering and Developablity ServiceFind More Therapeutic Antibody Categories