SC2: A MODERN APPROACH TO BIOLOGICS FORMULATION DEVELOPMENT

MONDAY, AUGUST 12 | 8:30 – 11:00 AM

ABOUT THIS COURSE:

This course offers a forum on how to develop sound formulations for biologic drugs. Case studies will be presented to demonstrate how to incorporate QbD concepts to do risk assessment, design multivariate experiments, and assess critical quality attributes including subvisible particle characterization to develop robust formulation for bulk drug substance or final drug product in the context of designated container closure systems. This course utilizes real-world examples and interactive discussion.

WHAT YOU WILL LEARN:

  • Quality by Design (QbD): an important concept and practice in modern drug development
  • Criticality of stability-indicating analytics for DS/DP formulation development
  • Rational experimental design (DOE) to obtain formulation design space
  • Challenges of high concentration protein formulation
  • Utilization of particle characterization to develop high quality formulation

INSTRUCTOR BIOGRAPHIES:

Zen_KevinKevin Zen, PhD, Executive Director, Analytical Characterization, Formulation Development, and Biologics Manufacturing, AnaptysBio Inc.

Kevin Zen has 25 years of experience in developing biologics drugs for clinical and commercial. He is currently an executive director responsible for analytical characterization, formulation development and drug product manufacturing at AnaptysBio in San Diego, USA.

Chou_DannyDanny K. Chou, PharmD, PhD, President, Biopharmaceutical Characterization and Formulation Development, Compassion BioSolution, LLC

Dr. Danny K. Chou is a biopharmaceutical industry veteran with expertise in biopharmaceutical characterization, formulation development, and emerging technologies for protein aggregate/subvisible particle analysis. Currently, Dr. Chou is the Founder and President of Compassion BioSolution, a biopharmaceutical consultancy and analytical testing service provider that serves clients throughout the world. Prior to starting Compassion BioSolution, Dr. Chou was a lead formulation scientist at Gilead Sciences, where he successfully converted IV formulations of monoclonal antibodies to high concentration formulations that are more stable and can be easily administered by subcutaneous injection. In the past 15 years, Danny has developed stable pharmaceutical dosage form for proteins, monoclonal antibodies, peptides, and oligonucleotides for clients ranging from small start-up biopharmaceutical companies to Fortune 500 pharmaceutical companies. Danny received his PhD from the University of Colorado Center for Pharmaceutical Biotechnology under the tutelage of Professor John Carpenter and his PharmD from the University of Florida.