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 the area of regulatory affairs, manufacturing and quality control.
This unique 3-days course is designed for advanced persons & specialists in the field of protein therapeutics or participants who have emphasis to jump into this 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 validation/qualification strategies, bioanalytical methods and process development as well as on regulatory needs and defined quality topics.
Manufacturing and process control for a monoclonal antibody
Concepts on process control and process validation
Bridge between process development & analytics
mAbs during clinical development – pitfalls & challenges
Identification & characterization of antibodies in human & animal models