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Monoclonal antibodies (which are exclusively given parenterally) have been proven to be an effective treatment in these cases. The use of auto-injectors is an effective strategy to improve drug adherence in parenteral treatments since these pen-like devices offer less discomfort and increased user-friendliness over conventional syringe-based delivery. This study aims to investigate the feasibility of including a monoclonal antibody as a solid formulation inside an auto-injector pen. Specifically, the objective was to evaluate the drug stability after a concentration (to reduce the amount of solvent and space needed) and freeze-drying procedure. A preliminary screening of excipients to improve stability was also performed. The nano-DSC results showed that mannitol improved the stability of the concentrated, freeze-dried antibody in comparison to its counterpart without it. However, a small instability of the CH2 domain was still found for mannitol samples, which will warrant further investigation. The present results serve as a stepping stone towards advancing future drug delivery systems that will ultimately improve the patient experience and associated drug adherence.<\/jats:p>","DOI":"10.3390\/pharmaceutics15082049","type":"journal-article","created":{"date-parts":[[2023,7,31]],"date-time":"2023-07-31T01:39:32Z","timestamp":1690767572000},"page":"2049","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["Stability of Monoclonal Antibodies as Solid Formulation for Auto-Injectors: A Pilot Study"],"prefix":"10.3390","volume":"15","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-0840-650X","authenticated-orcid":false,"given":"Fatima","family":"Garcia-Villen","sequence":"first","affiliation":[{"name":"NanoBioCel Group, Laboratory of Pharmaceutics, Faculty of Pharmacy, University of the Basque Country UPV\/EHU, 01006 Vitoria-Gasteiz, Spain"},{"name":"Biomedical Research Networking Centre in Bioengineering, 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