Therapeutic proteins and gene therapy are examples of biotechnological drugs. These drugs are very expensive, structurally complex and sensitive to working and handling conditions. It is therefore necessary to develop analytical techniques known as multi-attribute methods, which can provide specific information about protein structure. These techniques can be used to monitor the different degradation pathways which may be activated in a possible mishandling during preparation of the drugs for administration to patients in hospital settings. The various multi-attribute methods include peptide mapping in therapeutic proteins, an analytical technique in which both control and stressed samples are digested in smaller peptides that are analyzed by mass spectrometry previously separated by liquid chromatography. This technique assesses whether the everyday situations simulated in the stress test affect the structure of the therapeutic protein and consequently its safety and efficacy. With this information, hospitals can make better use of daily leftovers, so minimizing the cost of these drugs for public health services.
Keywords: Biotechnological drugs; multi-attribute methods; peptide mapping; safety; economy.
Directed by: Natalia África Navas Iglesias