Synopsis

The ability of protein-based therapeutics to provide highly specific, effective therapies make them suitable candidates for the treatment of chronic diseases. According to good manufacturing practice guidelines, protein therapeutics, so-called drug substances, need to be identified before manufacturing of the drug product. However, considering their complex structure, it is challenging to correctly identify therapeutic proteins in a cost and time efficient manner. Common analytical techniques for therapeutic protein identification are SDS-gel electrophoresis, enzyme linked immunosorbent assay, high performance liquid chromatography and mass spectrometry-based assays. Although effective in correctly identifying the protein therapeutic, most of these techniques need extensive sample preparation. This means that samples need to be removed from their containers. This step not only risks contamination but also the sample taken for identification is destroyed and cannot be re-used. Moreover, these techniques are often time consuming, sometimes taking several days to process. Thus, proper storage conditions to protect the protein drug substances in their native form are required. In collaboration with Sanofi-Genzyme in Waterford, researchers at the SSPC in Limerick have addressed these challenges by developing a rapid and non-destructive identification technique for protein therapeutics, specifically monoclonal antibodies. Raman spectroscopy in combination with chemometrics were used to identify three monoclonal antibody based drug substances.