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Area of Science:

  • Toxicologic Pathology
  • Biopharmaceutical Development
  • Respiratory Drug Delivery

Background:

  • Inhaled biotherapeutics (antibodies, proteins, peptides, nucleic acids) face regulatory hurdles due to poorly understood inhalation toxicity and immunogenicity.
  • Limited marketed inhaled biotherapeutics, besides Dornase Alfa and inhaled insulins, highlight a knowledge gap in the scientific community.
  • Existing scientific knowledge on inhaled biotherapeutics is fragmented, with scarce publicly available data.

Purpose of the Study:

  • To consolidate current knowledge on the pathology, toxicity mechanisms, and immunogenicity of inhaled biotherapeutics.
  • To provide a reference collection of manuscripts for toxicologic pathologists and toxicologists.
  • To address the challenges in the regulatory approval and development of inhaled biotherapeutics.

Main Methods:

  • Compilation of manuscripts focusing on toxicologic pathology of inhaled biotherapeutics.
  • Review of existing literature and generation of new data on inhalation toxicity.
  • Analysis of immunogenicity and safety profiles of inhaled biotherapeutics.

Main Results:

  • The collection addresses key aspects of inhaled biotherapeutic pathology and toxicity.
  • It provides insights into the immunogenic potential of different inhaled biotherapeutic classes.
  • Challenges in development and regulatory pathways are discussed.

Conclusions:

  • A comprehensive understanding of inhaled biotherapeutics' safety profile is essential for regulatory success.
  • This special edition serves as a vital resource for researchers and regulators in the field.
  • Further research is needed to fully elucidate the long-term effects and optimize delivery of inhaled biotherapeutics.