Webinar: The Journey to a Successful Biologic License Application

Date: 07 December 2017 Location: Online Event City: Online Event Country: Online Event

 

The road to a successful biologics license application (BLA) submission can be a long, complex journey. The chemistry, manufacturing, and controls (CMC) section of a successful BLA application, in particular, requires good planning, good science, and a thorough understanding of the process and product profile.

This webcast will provide insights into a structured approach to developing a tailored program for each product and process that considers all CMC aspects of a BLA program:

  • Risk assessment
  • Method validation
  • Process characterization
  • Process performance qualification (PPQ)
  • At-scale characterization activities in parallel with PPQ
  • Product comparability
  • Generation of the regulatory dossier  

  

Speakers

Jason Osman, Ph.D.

Head of Customer Proposals, Clinical Development and Licensing

Lonza Pharma & Biotech

 

John McGuire, Ph.D.

European Head of Regulatory Affairs, Mammalian

Lonza Pharma & Biotech

 

Click here to register

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