safety

Biopharmaceuticals are pharmaceutical products manufactured from biological sources, such as cell cultures, animals, etc. Examples of biopharmaceuticals include vaccines and therapeutic proteins, among others. In this research, we present a study to evaluate the safety of romiplostim, the active ingredient of drug, used to increase the level of platelets in blood. Romiplostim is a protein and as such, is susceptible to changes in its structure. These changes can be caused, for example, by exposure to high temperatures or poor storage. This can inhibit the function of the drug or even produce undesirable reactions in the patient.
In this research, we analyze these structural modifications using a multi-attribute method, involving digestion of the romiplostim (cleavage of its structure into peptides), separation of the resulting peptides and detection by mass spectrometry. The drug is subjected to certain specific situations in the laboratory that might induce changes in its structure (for example, exposure to light). In this way, we evaluate the stability of its properties when subject to a range of different conditions, in order to assess and ensure its safe use.

Keywords: biopharmaceuticals; therapeutic proteins; romiplostim; multi-attribute method; safety

Directed by: Natalia Navas Iglesias

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

Application of new methods for analyzing the safety of biopharmaceuticals – Mario Martínez Popeti

How to evaluate safety in biotechnological drugs? – Julio Ruiz Travé