MARCH 4-8, 2019
SHORT COURSE: THURSDAY MARCH 7, 6:00PM – 8:30PM
Advanced Analytical Technologies for Developability and Early Formulation Assessments
Danny K. Chou, PharmD, PhD, President, Compassion BioSolution, LLC.
Introduction:
For biopharmaceuticals, drug design, lead selection and formulation/manufacturing process development constitute significant areas of risk because of their decisive influence on product quality, biological activity and safety, as well as cost of goods. The purpose of this short course is to introduce how a range of advanced analytical technologies, along with the concept of Quality by Design (QbD) may be incorporated at the interface of drug discovery and development in order to both select drug candidates with the best inherent stability and deliver the most suitable formulation for these molecules. Part of the course will be focused on the practical tools (both conceptual tools and analytical tools) one can use to achieve this objective.
Topics to be covered:
- What are developability and formulability and how they relate to the principles of Quality by Design?
- How to assess formulability of a new therapeutic protein drug candidate: Define the suitability of a given drug candidate to be formulated for a desired route of administration or delivery method.
- What are some off-the-shelf tools that are available (statistical, time-saving approaches, and analytical tools that can help us assess molecules on attributes include, among others, solubility, aggregation, viscosity or product stability.
- A real case study of how one implements some of the tools mentioned above to evaluate new therapeutic protein drug candidates.
Who Should Attend?
Scientists, Project leaders, or Heads of departments for:
- Drug discovery
- Formulation
- R&D
- Analytical development
- Process development
- Technical development
- Pharmaceutical development
Instructor Bio:
Danny K. Chou, PharmD, PhD, President, 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.