Stability of Opened Durvalumab (IMFINZI) Vials. The Beginning of the End of Costly Product Wastage?

• Published in: Journal of pharmaceutical sciences 2023-09, Vol.112 (9), p.2412-2418
• Main Authors: Porlier, Alexandra, Gagnon, Pierre-Yves, Chénard, Valérie, Veillette, Marc, Bertrand, Nicolas, Duchaine, Caroline, Michael, Natalie J., Simard, Chantale, Drolet, Benoit
• Format: Article
• Language: English
• Subjects: Durvalumab; Microbiological stability; Physicochemical stability; Vial leftovers
• ISSN: 0022-3549; 1520-6017
• DOI: 10.1016/j.xphs.2023.06.014

Durvalumab is a monoclonal antibody approved for the treatment of lung, urothelial and biliary tract cancers. Durvalumab is supplied in vials as a solution containing no preservatives. Monographs recommend single use of durvalumab vials, and that any leftovers be discarded within 24 h. Thus, significant portions of unused product from opened vials are wasted on a daily basis, generating considerable financial losses. The objective of the present study was to assess the physicochemical and microbiological stability of durvalumab vials kept at 4 °C or room temperature, at 7 and 14 days after opening. Following pH and osmolality measurements, turbidity and submicronic aggregation of durvalumab solution were evaluated by spectrophotometry and dynamic light scattering, respectively. Moreover, steric exclusion high performance liquid chromatography (SE-HPLC), ion exchange HPLC (IEX-HPLC) and peptide mapping HPLC were used to respectively assess aggregation/fragmentation, charge distribution and primary structure of durvalumab. Microbiological stability of durvalumab was evaluated by incubation of vial leftovers on blood agar. All experiments showed physicochemical and microbiological stability of durvalumab vial leftovers for at least 14 days when aseptically handled and kept at either 4 °C or at room temperature. These results suggest the possible extension of utilization of durvalumab vial leftovers well beyond 24 h. [Display omitted]