Hilton San Diego Resort
San Diego, California
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.