Institute for International Research

Course Description

In this course you will learn strategies to plan preformulation and formulation development studies of protein therapeutics with the goal of maximizing the chemical and physical stability of the drug molecule while operating under accelerated timelines. A thorough understanding of protein conformation and the factors affecting conformation is vital for process development scientists and associates. The course begins with a section aimed at learning about the biophysical and biochemical properties of proteins as they pertain to protein structure and stability. Then, the typical workflow for preformulation/formulation projects is 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. The course concludes with real-world examples from formulation development projects for both liquid and lyophilized drug products.

Complete Course Agenda

• Protein chemistry and biophysics as they relate to protein structure and stability
• Maintenance of protein conformation for optimal stability and biological activity
• Common issues that affect physical and chemical stability of proteins, such as aggregation and deamidation
• Proven biophysical and analytical techniques to evaluate thermal, conformational and chemical stability of 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 Experiments (DOE) as a tool for protein formulation development
• Efficient design of preformulation and formulation programs for both liquid and lyophilized products
• Use of statistical analysis and DOE to identify critical factors and interactions that affect protein stability
• Interpret both biophysical and analytical data for the selection of lead formulations
• Lyophilization process development for proteins
• Optimization of final formulation properties
• Container-closure and delivery systems
• Approaches to mitigating risk during development projects as well as approaches for leveraging core analytical and biophysical tools across multiple projects.
• Case studies and real-world examples

Course Instructor

Timothy Kelly, Ph.D., Vice President, Biopharmaceutical Development, KBI Biopharma, Inc.
Tim Kelly has over 13 years of experience in protein and nucleic acid characterization. His responsibilities at KBI Biopharma include formulation, analytical and process development, as well as cGMP manufacturing and laboratory operations. At KBI Biopharma, Tim has overseen formulation development programs for approximately 20 protein and peptide products, with a particular emphasis on monoclonal antibodies. Prior to joining KBI Biopharma, Tim held the position of Director of Quality Control for Diosynth Biotechnology. He has considerable experience in the development, validation, and transfer of analytical methods for proteins. Tim's experience includes development, characterization, and production of over 30 clinical and commercial protein therapeutics, including monoclonal antibodies, enzymes, fusion proteins, peptides, and PEGylated proteins. Tim earned his Ph.D. in Biochemistry from Georgia State University. He is a member of AAPS and PDA.