When we get ill or suffer from a disease, we go to the doctor in search of a treatment that will make us better. With rare diseases, biotechnological drugs are used as treatments because they are more effective than their chemical counterparts. Biotechnological drugs are based on therapeutic proteins that are specifically designed to treat a particular illness. However, they tend to be more fragile and unstable than chemical ones. They can suffer alterations during the production phase and during shipping. 

They are more sensitive to environmental conditions such as exposure to the sun, temperature changes and brusque movements (for example during transport). Conscientious quality control is therefore essential before administration to the patient. 

My Master’s project focuses on the quality control of Ipilimumab, a therapeutic protein used in hospitals for treating melanomas and colorectal cancers among others. The method I apply involves subjecting the drug to controlled stress conditions, such as extreme temperatures, freezing, stirring, etc. I then compare the data obtained from the stress tests with the data for an unstressed control sample. The data are obtained using analytical techniques such as Liquid Chromatography.  

In this way, recommendations can be made regarding the correct handling of this drug, and we can avoid using it if it shows signs of degradation. 

Keywords: Therapeutic proteins- Environmental conditions- Quality control- Analytical techniques 

Directed by: Natalia África Navas Iglesias 

Cancer is one of the main causes of death in the world today. It is a disease involving body cells that have become immortal, so enabling them to grow rapidly, accumulate, and even invade other areas of the body. 

Ipilimumab is a drug designed to treat cancer. It is an antibody that recognises a protein (called CTLA-4) in the human body, so boosting our immune system’s ability to destroy cancer cells. 

These types of medicines have very high costs for healthcare systems and are usually administered in hospitals. Safe handling of these medicines in the hospital is an important issue, because as proteins they are very sensitive to the conditions to which they may be exposed during handling, storage or transport. For all these reasons, in this research we studied the stability of ipilimumab and its activity when subjected to a range of conditions that can arise in hospital settings, such as shaking, an increase in temperature or light exposure. In this way, we can provide healthcare professionals with the necessary information for the proper handling of ipilimumab, so as to ensure its safety and efficacy. Furthermore, the high price and the short stability of these drugs for administration to patients (around 24h) leads to the generation of many leftovers which, if studied using different analytical approaches, could be reused in a safe and effective way. Research of this kind could therefore create direct savings for the Public Health System and perhaps increase the number of treatments with these drugs. 

Keywords: Cancer, drug, ipilimumab, stability. 

Directed by: Natalia África Navas Iglesias