Large molecules, such as therapeutic antibodies, are an exponentially growing drug section and the analysis of these molecules in matrix is pivotal to support preclinical and clinical studies. In addition, the safety of large molecules is a major concern for both pharma/biotech and the regulatory authorities. Therefore, immunogenicity testing is also mandatory. Both aspects, bioanalysis and immunogenicity, are introduced in this course with a specialfocus on preclinical assessment with technologies, such as ELISA and LC-MS. Validation and troubleshooting of the assays are also an important part of this course l. Special attention is also given to biosimilars.
This course is conducted in cooperation with TNO Triskelion in Zeist and will be presented by Dr. Melody Sauerborn.
You are an analyst or researcher in a (bio) pharmaceutical/biotechnology laboratory, working on the analysis of therapeutic antibodies, biosimilars and other (new) bio pharmaceuticals. Research fields of your laboratory can also involve synthesis and production of glycoproteins or related compounds.
This course will be a mixture of theoretical background, real-life examples and practical cases. The course will be presented in Dutch.
You will be able to understand the practical basics to measure concentrations of a biopharmaceutical in matrix and antibody drug antibodies. In addition, the participant will understand the most recent theoretical basics and importance of bioanalysis and immunogenicity; why it became such important topics; the science behind it; regulatory requirements; how to address them and subsequently lead your product to market approval.
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