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SC2 QbD Strategies for Formulation Development of Protein Therapeutics

Monday, August 18, 2014 | 9:00 - 11:30am

This course offers a forum, discussing how to perform protein drug formulation development to meet Quality by Design expectations from the health authorities. A number of case studies will be presented to demonstrate how to design multivariate experiments, how to obtain dataset and how to analyze data in order to propose formulation of drug substance or drug product. The course will combine “how to” suggestions and real-world examples in an interactive discussion.

The topics to be covered:

  • QbD: Protein formulation strategies for regulatory filings
  • Force degradation and stability-indicating analytical methods
  • Application and utility of Design of Experiment (DoE) studies during early phase formulation development
  • Case studies: Multivariate analysis of data table
  • Design space of protein drug formulation

Instructors:

Steven LaBrenz, Ph.D., Scientific Director, Drug Product Development, Janssen R&D

Kevin Zen, Ph.D., Manager, Biologics Development, Allergan

Speaker Bios

StevenLeBrenzSteven LaBrenz, Ph.D., Scientific Director, Drug Product Development, Janssen R&D

Steven LaBrenz is a Scientific Director with Janssen R&D, LLC in the Drug Product Development division. He has been a member of the Parenterals and Liquids group since 2008, leading the areas of assay development, formulation development, product troubleshooting and high throughput screening. Steve earned his Ph.D. from Texas A&M University in Organic Chemistry and was both an NIH and ASEE post-doctoral fellow.

Kevin Zen, Ph.D., Manager, Biologics Development, Allergan

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