IBC Life Sciences

Description

The course provides an overview of biophysical techniques typically used in the development of biological products. You will learn the fundamentals of protein and peptide biophysical analysis using modern biophysical and spectroscopic techniques. You will review protein and peptide biophysical analysis and its relation to product characterization, process development, formulation, and stability development projects. Beginning with an introduction to protein conformation and the relationship to function and stability, we will delve into the basics of protein biophysics. Common biophysical techniques used to characterize protein and peptide conformation are discussed in detail with respect to theory and instrumentation, and examples are provided to illustrate the use of the techniques. The design of experiments for biophysical characterization is also discussed, with emphasis on the effect of pH and ionic strength on protein conformation. We will cover complementary biophysical techniques for monitoring conformational and colloidal stability as well as how to effectively use complementary biophysical techniques to monitor secondary, tertiary, quaternary, and higher-order protein structures. Applications of various biophysical techniques during formulation development, process development and comparability will be discussed using case studies.

Agenda

• Importance of Biophysical Analysis in Biologic Drug Product Development
• Protein Conformation and Structure
• Protein Biophysics
• Factors Affecting Protein Conformation
• Impact of Protein Conformational Changes on Stability
• Measuring Protein Conformational Stability
• Biophysical Techniques
  • UV-Vis and 2nd derivative UV spectroscopy
  • Circular dichroism
  • Fluorescence
  • FTIR
  • Raman
  • NMR
  • ESR
  • light scattering
  • DSC
  • AUC
• Use of DoE to Identify Critical Factors and Interactions on Protein Conformation
• Planning Biophysical Studies
• Interpreting Biophysical Analysis Data
• Case Studies
• Application of Biophysical Techniques:
  • formulation characterization
  • comparability
  • process development
  • manufacturing troubleshooting

Who Should Attend?

• Analytical Associates/Scientists/Senior Scientists
• Formulation Associates/Scientists/Senior Scientists
• Product Development Associates/Scientists/Senior Scientists
• Quality Assurance/Regulatory/Compliance/Quality Control Scientists
• Scientific Managers and Directors
• Scientists, Managers, and Associates involved in R&D, Biochemistry, Process Development and Characterization

Instructor

Ada Cowan, Ph.D., MBA, Pharmaceutical Formulation Leader, Battelle Memorial Institute
Dr. Cowan is a protein formulation leader at Battelle with over 19 years of experience in the development and characterization of protein products. She has developed both protein formulation platforms and novel protein stabilization technologies, and is experienced in the use of a variety of biophysical techniques (including UV-Vis, fluorescence, CD, DSC, FTIR, NMR, ESR and DLS) to develop and characterize protein formulations. Prior to assuming her current position at Battelle, Dr. Cowan was a formulation director at Ventaira Pharmaceutical where she developed protein inhalation products and established the company's biophysical analysis capabilities. She obtained her Ph.D. in Biochemistry at The Ohio State University and completed her post-doctoral research at the Massachusetts Institute of Technology where she studied protein structure/function relationships, enzyme kinetics and protein-protein interactions. She has coauthored 17 scientific publications, and has one issued patent with several patents pending that relate to protein products.