Project funded by the European Regional Development Fund (ERDF):
Identification of markers for quality and stability of blood products using protein pattern, exemplarily demonstrated by the use of serum eye drops.
Pharmaceutical companies that market blood products are bound by a large number of regulations. However, there are no established analytical methods to verify the consistent quality or stability of blood products based on their ingredients. However, as most biological products are subject to their inherent variability, these must be defined by clear limits and strictly controlled by manufacturers and regulators. Since the Paul Ehrlich Institute, the regulatory authority for biological drugs, has recommended human serum for the treatment of dry eyes (Sicca-Syndrome), a quality and stability control is to be developed in this project by means of the proteins in human serum or serum eye drops. This will be performed by the generation of specific protein patterns based on the proteome analysis.