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Meet the training leaders

  • Dr. Markus Fido
  • Chief Executive Officer
  • VelaLabs GmbH
Learn more about the trainer
  • Dr. Dietmar Reusch
  • Characterization Analytics & Development, mAbs
  • Roche Diagnostics, Germany
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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

Learn how to deal with mAbs

Discuss & understand manufacturing, process control & process validation for a monoclonal antibody

Gain insight in development strategies

Practice on case studies

Get tips & find solutions

Ticket

Online Live Stream

from 1296 € Buy

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