Monoclonal antibodies are biotechnological drugs whose study and use has increased in recent years as they have better efficacy and fewer side effects than the other older therapies. However, due to their intrinsic fragility, these proteins require particular attention in their formulation, storage and use. In this project, biochemical and biophysical techniques were used to study Libtayo® (Cemiplimab) and Yervoy® (Ipilimumab), monoclonal antibodies used for the treatment of skin cancer. The studies were conducted under stress conditions caused by exposure to sunlight and dilutions in buffers at different pH. Analyzes under these conditions were carried out to verify the stability differences of the studied antibodies, with particular attention paid to the different excipients present in the commercial formulation. It is useful to carry out chemical-physical studies on biotechnological drugs aimed to understand the problems of the product, increase the knowledge relating to the storage of the drug based on its composition and formulation and finally to raise awareness of a more conscious handling guaranteeing the maintenance of the quality, safety and efficacy standard.
Gli anticorpi monoclonali sono farmaci biotecnologici il cui studio e utilizzo è incrementato sempre più negli ultimi anni in quanto presentano una migliore efficacia e minori effetti collaterali delle altre terapie precedentemente in commercio. Tuttavia, per la loro fragilità intrinseca, queste proteine richiedono particolari attenzioni nella formulazione, conservazione ed utilizzo. In questo progetto sono state utilizzate tecniche biochimiche e biofisiche per lo studio di Libtayo® (Cemiplimab) e Yervoy® (Ipilimumab), anticorpi monoclonali utilizzati per il trattamento del carcinoma cutaneo. Gli studi sono stati condotti in condizioni di stress causate dall’esposizione alla luce solare e diluizioni in buffers a diverso pH. Le analisi in queste condizioni sono state svolte per verificare le differenze di stabilità degli anticorpi studiati, con particolare attenzione rivolta ai diversi eccipienti presenti nella formulazione commerciale. È utile svolgere studi di tipo chimico-fisico sui farmaci biotecnologici in modo tale da comprendere le problematiche del prodotto, incrementare le conoscenze relative allo storage del farmaco in base alla sua composizione e formulazione ed infine per sensibilizzare ad una manipolazione più consapevole garantendo il mantenimento degli standard di qualità, sicurezza ed efficacia.
Studio di stabilità di Libtayo, Yervoy e Opdivo in condizioni di stress: effetti dell'esposizione alla luce e a variazioni di pH
CECCHIN, ELEONORA
2021/2022
Abstract
Monoclonal antibodies are biotechnological drugs whose study and use has increased in recent years as they have better efficacy and fewer side effects than the other older therapies. However, due to their intrinsic fragility, these proteins require particular attention in their formulation, storage and use. In this project, biochemical and biophysical techniques were used to study Libtayo® (Cemiplimab) and Yervoy® (Ipilimumab), monoclonal antibodies used for the treatment of skin cancer. The studies were conducted under stress conditions caused by exposure to sunlight and dilutions in buffers at different pH. Analyzes under these conditions were carried out to verify the stability differences of the studied antibodies, with particular attention paid to the different excipients present in the commercial formulation. It is useful to carry out chemical-physical studies on biotechnological drugs aimed to understand the problems of the product, increase the knowledge relating to the storage of the drug based on its composition and formulation and finally to raise awareness of a more conscious handling guaranteeing the maintenance of the quality, safety and efficacy standard.File | Dimensione | Formato | |
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https://hdl.handle.net/20.500.12608/42398