Inspiration and Exasperation: The Challenges of Inhaled Biologics.

Inspiration and Exasperation: The Challenges of Inhaled Biologics. Toxicol Pathol. 2021 Jan 05;:192623320984715 Authors: Hall P, Vahle JL, Colman K 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. PMID: 33397211 [PubMed - as supplied by publisher]
Source: Toxicologic Pathology - Category: Pathology Authors: Tags: Toxicol Pathol Source Type: research