Biologics Analytical Methods: Trends and Strategies to Accelerate Biologics Development

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Event Details:

This webinar, co-organized with bioPmed, will summarize the current biologics analytical landscape and its challenges, as well as discuss strategies to overcome them. Experts will describe how the stepwise approach for biologics analytical testing can be used to reduce risks and challenges present in biologics development. In addition, we will also discuss how the biologics analytical plans can be tailored to fit study needs at all project stages and its implications for CMC regulatory submission of biologic products. 
Biologics Analytical Considerations: Lifecycle Management from Preclinical to Commercial 
Roberta Bucci, Principal Scientist, Bioanalytical Development,
Catalent Biologics 
  • An introduction to the analytical testing landscape. 
  • Catalent’s stepwise approach for analytical testing. 
  • Common challenges in analytical testing of biologics programs, and strategies to overcome them.  
Regulatory Strategy of Biologic Development Plans with a Focus on Analytical Development Packages 
Julien Massiot, Ph.D., Senior Project Manager,
Leads to Development

  • Regulatory CMC strategy for biologics development. 
  • Overview of analytical target profile. 
  • What do the guidelines say on phase appropriate qualification/ validation of bioanalytical method. 
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