Course No 16209
|Non-ECA Members:||EUR 890,--|
|ECA Members:||EUR 790,--|
|EU GMP Inspectorates:||EUR 445,--|
|APIC Members (does not include ECA membership):||EUR 850,--|
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During this course you will get to know the relevant aspects of stability testing for biological and biotechnological drug substances and drug products. You will learn about
The active components in biotechnological/biological products are typically proteins and/or polypeptides. They have distinguishing characteristics to which consideration should be given in any well-defined testing program designed to confirm their stability during the intended storage period. The products are particularly sensitive to environmental factors such as temperature changes, oxidation, light, ionic content, and shear. In order to ensure maintenance of biological activity and to avoid degradation, stringent conditions for their storage are usually necessary.
The evaluation of stability may necessitate complex analytical methodologies. Appropriate physicochemical, biochemical and immunochemical methods for the analysis of the molecular entity and the quantitative detection of degradation products should also be part of the stability program.
In order to get the approval to conduct a clinical trial data have to be presented on the biological, chemical and pharmaceutical quality of Investigational Medicinal Product (IMP). In the new Guideline on the Requirements for Quality Documentation Concerning Biological Investigational Medicinal Products in Clinical Trials particular provisions are laid down on how to document stability and other quality related data within the CTD structure.
Stability Testing of Biological and Biotechnological Drug Substances and Drug Products