Course description
Monoclonal antibodies are among others top selling drugs and blockbusters of new protein therapeutics and show a high dominance of different market segments. With the increasing interest of these products class, as well as the rapid growth in the preclinical and clinical development, unique challenges have emerged especially in regulatory affairs, manufacturing, process development and quality control.
This unique 3-day course is designed for advanced persons & specialists in the field of protein therapeutics or participants who have emphasis to jump into this exciting new business field. We will provide a course to introduce you in the field of monoclonal antibodies, give you practical & in-depth understanding of this segment of therapeutics – in general, about their development, method qualification / validation strategies, for bioanalytical methods, technical challenges, and different kind of process development as well as on regulatory needs and defined quality topics.
