Meet the training leaders
- Dr. Markus Fido
- Founder, Managing Director
- Mfi Bio-Consulting, Meridian Biopharmaceuticals, Austria
- Dr. Dietmar Reusch
- Director Development Characterization
- Roche Diagnostics, Germany
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 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.
Key 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
Benefits of attending
Testimonials
Thanks for the great course! I appreciated the course quality, engagement and skills of the trainers.
Thank you for very informative and useful three days!
Many thanks to the trainers, I enjoyed the training!
Trainers provided a very comprehensive overview on the aspects of mAb clinical, development and regulatory aspects and this was a great learning for me.
Contact us
- Andrea Weber
- Sr. Manager for Pharma
- Phone: +421 257 272 232
- Email: event.inquiries@fleming.events