The Journey to a Successful Biologic License Application

Dec 07, 2017
By Lonza

Register Free: http://www.pharmtech.com/pt_w/biologic

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, PhD, Head of Customer Proposals, Clinical Development and Licensing, Lonza Pharma & Biotech

John McGuire, PhD, European Head of Regulatory Affairs, Mammalian, Lonza Pharma & Biotech

 

Date and Time:

Live: Thursday, Dec. 7, 2017 | 12 pm EST | 11 am CST | 9 am PST

After the final airing of the webcast on Dec. 7, 2017 it will be available on demand until Dec. 7, 2018. 

Sponsor: Lonza

Register Free: http://www.pharmtech.com/pt_w/biologic

native1_300x100
lorem ipsum