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!
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
Challenges and Solutions for Complex Biologics CMCYing Li, Director of Antibody R&D and Purification PD Dept., ProBio
Discuss 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
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
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info@wilam.comAn initiative ofBioMelbourne NetworkLevel 6, HWT Tower40 City RoadSouthbank, VIC 3006
Wilam means home in the Woi-wurrung language of the Wurundjeri People of the Kulin Nation, the Traditional Owners of the lands on which we are based.We respectfully acknowledge the Traditional Custodians of the unceded lands and waters of Victoria, the Bunurong, Eastern Maar, Gunaikurnai, Wadawurrung and Wurundjeri Woi-wurrung peoples, on which we live and work. We pay respect to their Elders past and present. We acknowledge the significant contribution that they and other Aboriginal and Torres Strait Islander people have made and continue to make to the research and knowledge systems that inform our community and our sector. We acknowledge that Aboriginal and Torres Strait Islander people continue to live in a spiritual and sacred relationship with this country and recognise our responsibility to continue to work towards reconciliation.