Evaluation of Biologics ACE2/Ang(1-7) Encapsulated in Plant Cells for FDA Approval: Safety and Toxicology Studies.

ABSTRACT: Background/Objectives: For several decades, protein drugs (biologics) made in cell cultures have been delivered as sterile injections, decreasing their affordability and patient preference. Angiotensin Converting Enzyme 2 (ACE2) gum is the first engineered human blood protein expressed in plant cells approved by the FDA without the need for purification and is a cold-chain and noninvasive drug delivery. This biologic is currently being evaluated in human clinical studies to debulk SARS-CoV-2 in the oral cavity to reduce coronavirus infection/transmission (NCT00543318). Methods: Chemistry, manufacturing, and control (CMC) studies for the ACE2/Ang(1-7) drug substances (DSs) and ACE2 gum drug product (DP) were conducted following USP guidelines. GLP-compliant toxicology studies

SUBMITTER: Daniell H 

PROVIDER: S-EPMC11768411 | biostudies-literature | 2024 Dec

REPOSITORIES: biostudies-literature