Bioprocess Training Academy - Two-Day Training Courses for Spring 2012 -
2012年4月16-17日 · Omni Parker House · Boston, MA
"This course was definitely worthwhile, the material was directly relevant to my current work! I look forward to it's application."
- E. Weston, Associate Scientist II, GSK Biologicals
Who Should Attend?
Audio and/or video recordings are not permitted.
Certificate of Attendance: All participants who complete the course will receive a certificate of attendance at the conclusion of the class.
Basics of Protein Formulation Development
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.
Timothy Kelly, Ph.D., Vice President, Biopharmaceutical Development, KBI Biopharma, Inc.
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