Laura Niklason – VJRegenMed

The industrialization of regenerative medicine

Simon Ng — Fri, 14 Jan 2022 16:12:13 +0000

Laura Niklason, MD, PhD, Yale University, New Haven, CT & Humacyte, Durham, NC, describes the mass manufacturing of advanced therapies, including bioengineered human vessels. Various stimuli, as well as growth and physical factors were identified that can successfully stimulate the growth of new arteries from vascular cells. Dr Niklason emphasizes the need to keep those conditions constant to industrialize the production of blood vessels, and instead of scaling up, a scaling out approach should be adopted, where the manufacturing process is repeated in multiple bioreactors. This interview took place at the 6th World Congress of the Tissue Engineering and Regenerative Medicine International Society (TERMIS 2021).

Overcoming hurdles associated with commercializing advanced therapies

Simon Ng — Fri, 14 Jan 2022 16:12:12 +0000

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).

Technological advances in human acellular vessels

Simon Ng — Fri, 14 Jan 2022 16:12:11 +0000

Laura Niklason, MD, PhD, Yale University, New Haven, CT & Humacyte, Durham, NC, provides an overview of the development process of human acellular vessels (HAVs). Initial autologous approaches to create blood vessels from animal sources proved unsuitable for clinical translation, and a novel method of decellularizing smooth muscle cells on a scaffold have demonstrated success in a number of patients. HAVs have proven to be non-immunogenic and have a long shelf life of 18 months, representing a promising therapy for patients who require vascular grafts. This interview took place at the 6th World Congress of the Tissue Engineering and Regenerative Medicine International Society (TERMIS 2021).