2nd International Symposium on Higher Order Structure of Protein Therapeutics
11 Feb 2013 - 13 Feb 2013 - Baltimore, MD, USA
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.