IBC Life Sciences

Description

In this course, you will learn strategies to plan and execute preformulation and formulation development studies of protein therapeutics, with the goal of maximizing the chemical, physical, conformational, and biological stability of the drug molecule while operating under accelerated timelines. A thorough understanding of protein conformation and the factors affecting conformation is vital for scientists engaged in formulation development. The course begins with an overview of biophysical and biochemical properties of proteins as they pertain to protein structure and stability. Following this introduction, the typical workflow for preformulation/formulation projects will be outlined to demonstrate the core elements employed during protein formulation. Statistical analysis and design of experiments are discussed, with particular emphasis on the application of these tools to better understand critical factors and interactions that impact protein stability. Finally, the course concludes with real-world examples from formulation development projects for both liquid and lyophilized drug products.

Who Should Attend?

The course covers the fundamental concepts and techniques which govern protein formulation development, and is applicable for:

• Scientists working in formulation, drug delivery and pharmaceutical sciences
• Scientists, Associates, and Engineers involved in development or quality control
• Managers responsible for supervising development projects
• Process development and manufacturing Scientists and Associates

Instructors

Pooja Arora, Ph.D., Research Investigator II, Bristol-Myers Squibb Co.
Pooja Arora has more than eight years of experience in protein biophysical and analytical characterization. Her responsibilities at BMS include formulation development studies for protein therapeutics to identify conditions that impart optimum physical, chemical and biological stability. Prior to BMS, she was at KBI Biopharma Inc. where she was the technical lead for projects that focused on preformulation development, stability studies, and biophysical and analytical characterization. Pooja earned her Ph.D. from Duke University.

Timothy Kelly, Ph.D., Vice President, Biopharmaceutical Development, KBI Biopharma, Inc.
Tim Kelly has over 15 years of experience in protein and nucleic acid characterization. His responsibilities at KBI Biopharma include formulation and analytical development, as well as cGMP laboratory operations. At KBI Biopharma, Tim has overseen formulation development programs for over 35 protein and peptide products, with a particular emphasis on monoclonal antibodies. Tim earned his Ph.D. in Biochemistry from Georgia State University.