Recent advances in genomics, proteomics, recombinant expression technologies, and peptide synthesis have led to an increased development of protein and peptide therapeutics.

Due to improved and simplified manufacturing techniques, disregard for patent protection, and a growing global market for non-approved drugs, several peptide or protein drugs are being manufactured illicitly and are being made available to the public before entering or completing clinical trials. The Belgian Federal Agency for Medicines and Health Products (FAMHP) and customs are striving, together with their global counterparts, to curtail the trafficking and distributions of these substances. At the request of the FAMHP, unknown pharmaceutical preparations suspected to contain illegal protein and/or peptide drugs are regularly subjected to analysis by our OMCL laboratory.

Here, we elaborate on the techniques we employ to analyze such samples and give an overview of the substances we’ve encountered during the last decade.