This study, published in European Journal of Pharmaceutics and Biopharmaceutics, investigates the behavior of the therapeutic mAb ipilimumab (Yervoy®), used for the treatment of melanoma and other types of cancer, when exposed to every-day stressors. The results suggest that special warning must be paved on protein aggregation phenomena, which could compromise not only the efficacy of the drug itself but also its correct administration to the patient (i.e., obstruction of needles and lines). Moreover, this mAb appeared to be very stable to vibration and temperature fluctuations but not to light before and after dilution and should be always stored protected from light.

A detailed knowledge of the drug properties, integrity, and stability can assure the best storage and handling for its safe and successful application in cancer therapy.

– We hope that this work might be useful for the healthcare personnel and patients to assure the proper use and storage of biotechnological therapeutic drugs in all the real-life steps such as the vibration and temperature during transport, storage, manipulation and administration. Each biotechnological drug need its own stability study as they show their specific structure, more or less sensitive to environmental changes. Therefore, we recommend individual experiments for each of them, says Patrizia Polverino de Laureto.

The work was conducted in collaboration between University of Padova and University of Dundeein the RealHOPE project.

Authors: Benedetta Fongaro, Valentina Cian, Francesca Gabaldo, Giorgia De Paoli, Giorgia Miolo, Patrizia Polverino de Laureto 

Link to the publication