EV Biologics report that it has designed a modular process for production of extracellular vesicles (EVs) with native therapeutic properties, beginning with optimized producer cells. The company has been in talks with several major biotechnology and pharmaceutical manufacturing companies to develop cGMP bioprocessing and enable large-scale EV biomanufacturing based on this process, according to its CEO, Daniel McKinney.

“Establishing a scalable, standardized, EV manufacturing process is just the beginning of our therapeutic exosome development initiative,” he says. “This process will allow us to reliably produce and study both native exosomes and those engineered specifically for our selected clinical indications.”

“Our EV production process, comprising automated modular systems for continuous bioprocessing, will standardize production of therapeutic exosomes for preclinical study. A rigorous biomanufacturing protocol will be essential in preparation of regulatory submissions for our investigational exosome biopharmaceuticals,” adds Jason Sanders, MD, chief medical officer, who notes that the Cheyenne, WY-based company plans to begin preclinical studies of its first exosome biopharmaceutical candidates in Q4 2021.

Exosomes are biological nanoparticles released by cells as an intercellular communication system to transport biomolecules. They have the ability to deliver therapeutics or regenerate tissue in several pathologies, including osteoarthritis, heart failure, and liver and kidney diseases.