Speakers -------- N/A Post-translational Modifications looks at the potential impact of PTMs on product quality and function. Biopharmaceuticals are subject to post-translational modifications at every step of development and manufacturing, and analytical methods for detecting these PTMs are improving by leaps and bounds. This track will provide case studies on physicochemical analysis and functional testing of PTMs, explore how PTM analyses can be used to support manufacturing, and how PTMs can be harnessed for product optimization, for example in antibody engineering, clone selection, and development of formulation. Regulatory perspectives in terms of new guidance, regulatory experience and precedence will be included.
|Tuesday, April 13, 2010|
|Wednesday, April 14, 2010|