Inspiration and Exasperation: The Challenges of Inhaled Biologics. (February 2021)

• Record Type: Journal Article
• Authors: Hall, Peter; Vahle, John L.; Colman, Karyn
• Other Names: Colman Karyn guest-editor.; Hall Anthony Peter guest-editor.; Vahle John guest-editor.
• Is Part Of: Toxicologic pathology. Volume 49:Number 2(2021)
• Page Start: 232
• Page End: 234
• Publication Date: 2021-02
• Subjects: inhaled biologics -- pathology -- bronchoalveolar lavage -- adversity -- immunogenicity -- mechanisms; Pathology -- Periodicals; Toxicology -- Periodicals; Pathology; Toxicology; 615.9
• DOI: 10.1177/0192623320984715
• Languages: English
• ISSNs: 0192-6233

Abstract

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.