Course No 15523
If you have any questions, please contact us:
Tel.: +49 (0)6221 / 84 44 0 E-Mail: firstname.lastname@example.org
Rainer Fedra, VelaLabs, Austria
Markus Fido, VelaLabs, Austria
Tino Galgon, IDT Biologika, Germany
Siegfried Giess, Paul Ehrlich Institute, Germany
Ulrike Herbrand, Charles River Laboratories, Germany
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 basic requirements of stability testing and stability study design from the supervisory authority’s view the peculiarities of stability indicating analytical methods
optimising strategies regarding packaging and storage of biological/biotechnological material how to submit stability data for a marketing authorisation dossier according to the new Guideline on Quality Documentation.
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