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.

Instructor

Timothy Kelly, Ph.D., Vice President, Biopharmaceutical Development, KBI Biopharma, Inc.

Course Agenda

• Protein chemistry and biophysics as they relate to protein structure and stability
• Maintenance of protein conformation for optimal stability and biological activity
• Physical and chemical stability of proteins
• Degradation pathways relevant to proteins and shelf life
• Biophysical and analytical techniques for proteins
• Buffers and excipients relevant to protein formulation
• Route of administration concerns
• Typical workflow for formulation development projects
• Strategic selection of formulation components for baseline screening
• Design of preformulation programs for liquid and lyophilized products
• Statistical design of experiments to identify effects and interactions
• Interpretation of both biophysical and analytical data
• Lyophilization process development for proteins
• Forced degradation studies to support formulation selection
• Optimization of final formulation properties
• Container-closure and delivery systems
• Case studies and real-world examples