Browse views: by Year, by Function, by GLF, by Subfunction, by Conference, by Journal

Inspiration and Exasperation: The Challenges of Inhaled Biologics

Hall, Peter, Vahle, John and Colman, Karyn (2021) Inspiration and Exasperation: The Challenges of Inhaled Biologics. Toxicologic Pathology. ISSN 15331601


The delivery of biotherapeutic molecules (antibodies, proteins, peptides) and nucleic acids via the respiratory route has presented challenges for regulatory approval, due in part to a lack of understanding of the expected pathology, mechanisms of toxicity, and immunogenicity induced by the inhalation route. Although the first inhaled biotherapeutic was approved some time ago (Dornase Alfa, Pulmozyme; Genetech, 1993), no other inhaled biotherapeutics have been marketed for the treatment of human disease other than the inhaled insulins (Exubera; Pfizer, 2006 and Afrezza; Mannkind Corporation, 2014). As a result, scientific knowledge within the toxicologic pathology community is fragmented with precious little publicly available data. Therefore, one of the aims of this special edition was to generate a collection of manuscripts that pathologists and toxicologists could refer in order to understand the pathology, mechanisms of toxicity, immunogenicity, and challenges associated with the development of inhaled biotherapeutics.

Item Type: Article
Keywords: adversity bronchoalveolar lavage immunogenicity inhaled biologics mechanisms pathology
Date Deposited: 13 Feb 2021 00:45
Last Modified: 13 Feb 2021 00:45


Email Alerts

Register with OAK to receive email alerts for saved searches.