TERMIS 2021 | Overcoming hurdles associated with commercializing advanced therapies

Laura Niklason, MD, PhD, Yale University, New Haven, CT & Humacyte, Durham, NC, discusses challenges associated with the commercialization of human acellular vessels (HAVs), bioengineered blood vessels. Mass manufacturing of HAVs require careful consideration of maintaining the conditions that allows growth of new vessels from vascular cells, and the LUNA200 system enables large-scale growth in bioreactors. Dr Niklason additionally highlights the importance of clinical trial design, where focusing on efficacy is as paramount as product safety, as well as liaising with the FDA for regulatory approval. This interview took place at the 6th World Congress of the Tissue Engineering and Regenerative Medicine International Society (TERMIS 2021).