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 SHORT COURSE 9: PROTEIN AGGREGATION: MECHANISM, CHARACTERIZATION AND CONSEQUENCES


Protein aggregation is recognized by regulatory agencies and the biopharmaceutical industry as a key quality attribute of biotherapeutic products. Various aggregates hold the potential for adversely impacting production and patients in a variety of ways. This in-depth workshop reviews the origins and consequences of aggregation in biotherapeutics, and then examines strategies for predicting and quantifying aggregation in biopharmaceuticals. It benefits scientists engaged in development, production, analytical characterization and approval of biotherapeutics and who require a good working knowledge of protein aggregation.

Topics to be discussed:

  • Which phenomena are described by the term “protein aggregation?
  • How does protein aggregate form, and what factors influence their formation?
  • What are the mechanisms of protein aggregations?
  • How do aggregate size, morphology and surface chemistry determine immunogenicity?
  • How can protein aggregation be predicted?
  • What changes may be made to the protein and solvent to minimize aggregation?
  • What are the key analytical challenges in characterizing protein aggregates?
  • Analytical tools for prediction and quantification of protein aggregates

Instructors:  

Thomas Laue, Ph.D., Professor, Biochemistry and Molecular Biology; Director, Biomolecular Interaction Technologies Center (BITC), University of New Hampshire 

David F. Nicoli, Ph.D., Vice President R&D, Particle Sizing Systems, LLC

 

Speaker Biographies: 

Thomas LaueThomas Laue, Ph.D., Professor, Biochemistry and Molecular Biology; Director, Biomolecular Interaction Technologies Center (BITC), University of New Hampshire   

Tom Laue is the Carpenter Professor of Molecular, Cellular and Biomedical Sciences, and professor of Material Sciences at the University of New Hampshire. He is the Director of both the Center to Advance Molecular Interaction Science and the Biomolecular Interaction Technologies Center.

He received his bachelor’s degree in Natural Sciences from the Johns Hopkins University in 1971 and his Ph.D. in Biophysics and Biochemistry from the University of Connecticut in 1981. His post-doctoral studies were conducted at the University of Oklahoma. Between 1969 and 1975, he worked as a technician in the deep space program of NASA.

He joined the University of New Hampshire in 1984 as an Assistant Professor, and teaches both undergraduate and graduate courses in biochemistry and biophysics. His research focuses on the development of instrumentation and methods that use the fundamental properties of mass and charge for examining macromolecular interactions. These instruments provide unique insights into these interactions, and have resulted in extensive collaborations with both academic and industrial labs. Tom has over 120 publications, serves on several editorial boards, and gives over one hundred lectures, seminars and workshops a year.

David F. Nicoli, Ph.D., Vice President, R&D, Particle Sizing Systems, LLC

Received B.S. (MIT) and PhD (Harvard) in Physics. Founded Nicomp Instruments (1978), acquired by Hiac-Royco/Pacific Scientific (1984). Co-founder and President of Particle Sizing Systems (1989), acquired by Agilent Technologies (2008). Currently Vice-President of PSS LLC, assets re-acquired from Agilent (2009).


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