CASSS - An International Separation Science Society

Higher Order Structure 2011

Monday, September 26, 2011 - Wednesday, September 28, 2011

1st International Symposium on Higher Order Structure of Protein Therapeutics

Wasfi Al-Azzam, GlaxoSmithKline Pharmaceuticals
John Dougherty, Eli Lilly and Company

Biophysical properties such as protein conformation, protein dynamics, self-association, aggregation and particulate formation contribute either individually or collectively to the quality attributes of protein therapeutics. There is thrust from the FDA to characterize the biophysical properties of protein therapeutics (i.e. conformation and higher order structure as early as possible in the development cycle) so as to assess how protein structure is affected by  manufacturing, storage and delivery; thereby evaluating its impact on clinical safety and efficacy.

A noticeable lack of understanding of existing biophysical characterization methods used in monitoring the quality attributes of protein therapeutics such as conformation and higher order structure has created hurdles in the application of these technologies for evaluating drug safety. Additionally, since most biophysical analyses provide ensemble average structural information of the molecules, it is essential to evaluate if the observed changes are significant and cannot be attributed to assay or process variability. Use of the appropriate biophysical method, method development and qualification to characterize the quality attributes at different stages of the product lifecycle are therefore a matter of interest and debate for a wide range of audiences.

Collectively, members from academic, regulatory, and industrial institutions believe that it is the right time for a conference that will involve in-depth discussion and data-sharing on the characterization of higher order protein structure and its biological implications. This Symposium will focus on various biophysical characterization methods, the theory and practice of biophysics, technical data from academia and industry as well as method qualification, validation and setting specifications.  This Symposium is intended be the first in an on-going series.  Topics relevant to the biophysical characterization of protein therapeutics may include the following:

• Assessing relevant technologies
• Development and validation of biophysical methods
• Impact of process, formulation, and device changes
• Establishing acceptance criteria for biophysical methods
• Leveraging biophysical methods in the development of design spaces

We urge professionals from the following functions to not only attend but to fully engage in these important discussions:

  • Discovery Sciences
  • Process/Product Development
  • Formulation Development
  • Quality Assurance/Quality Control
  • Regulatory Affairs
  • Immunology
  • Molecular and Cell Biology
  • Analytical Development
  • Manufacturing Sciences
  • Clinical Pharmacology


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