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SHORT COURSE 3: A RATIONAL APPROACH
TO FORMULATION DEVELOPMENT OF BIOLOGIC THERAPEUTICS

Sunday, January 18 | 5:00-8:00 pm  

The course offers a forum discussing how to develop formulation for biologic drugs. A number of case studies will be presented to demonstrate how to incorporate Quality-by-Design (QbD) concept to design multivariate experiments, how to obtain representative data, and how to analyze data in order to propose sound formulation of drug substance or drug product in the context of designated container closure systems. The course will combine ”how to” suggestions and real world examples in an interactive discussion.

Topics Include:

  • Develop stability-indicating analytics for formulation development by accelerated degradation
  • Rational experimental design (DOE) for early-phase drug product
  • Robust formulation and process characterization for late-phase drug product
  • Harness high concentration protein formulation
  • Confirmation of stability and compatibility of the final delivery dosage forms

Instructors:

Steven LaBrenz, Ph.D., Scientific Director, Drug Product Development, Janssen R&D
Kevin Zen, Ph.D., Manager, Biologics Development, Allergan

 
Speaker Biographies:   

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

SteveLaBrenzSteven 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’s areas of expertise include polysorbate chemistry and oxidation reactions in protein formulations.  He is currently collaborating with Princeton University on large-scale formulation stability modeling. Steve earned his B.S. in Biochemistry from Northern Michigan University, 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., Senior Manager, Biologics Development, Allergan

Kevin ZenKevin Zen has over 20 years of experience in biologics drug development. In his role at Allergan, Kevin is responsible for analytical development, formulation development, biophysical characterization, drug product manufacturing process development, and biologics stability management. Prior to joining Allergan, Kevin held the position of Associate Director at Cardinal Health Pharmaceutical Technologies and Services, where he was responsible for analytical development/qualification/validation, QC release/stability, extended characterization, formulation development of liquid and lyophilized dosage forms for intravenous and subcutaneous administration. Prior to Cardinal Health PTS, he worked on cell line development, protein expression, upstream and downstream process development for 10 years in Johnson and Johnson, AstraZeneca, and Becton Dickinson. Kevin obtained his PhD in Biomedical Sciences from the Mount Sinai School of Medicine in New York and did his postdoctoral research on transmembrane protein structure function in Ronald Kaback’s lab at Howard Hughes Medical Institute.



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