Enzyvant says the construction of a regenerative medicine facility in Morrisville, North Carolina will bolster its size, flexibility, and capability to support its commercial needs.
Financial details of the expansion remain under wraps, but regenerative medicine focused firm Enzyvant says the development of a 25,972 square-foot facility will begin this summer and take around two and a half years to complete.
The plant is located within the Research Triangle Park area and is being co-developed by and operated with Sumitomo Pharma, which owns Enzyvant’s immediate parent company, Sumitovant Biopharma.
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“We’re excited that this new site not only expands the range and scope of our manufacturing offerings, but also builds our presence in Research Triangle Park – leveraging our existing employee base and support the local area with new hires,†said Larry Weiner, VP of pharmaceutical development & manufacturing at Enzyvant.
The firm says the facility will largely focus on manufacturing Rethymic (allogeneic processed thymus tissue-agdc), the first thymus tissue product approved by the US Food and Drug Administration (FDA).
Rethymic aims to treat pediatric patients with congenital athymia, a rare immune disorder. The one-off treatment works by inserting small slices of tissue into the quadriceps muscle in the thigh with the aim to rebuild immune function in infants born without a thymus gland.
“Enzyvant is committed to ensuring scalable GMP manufacturing for RETHYMIC and we’re looking ahead to potential needs in other indications and in support of other advanced regenerative medicine technologies,†said Enzyvant CEO William Symonds.
“This new facility, once completed, will give us the size, flexibility, and nimble processing capability to serve both commercial and research needs.â€
According to Enzyvant, it has specific capabilities in advanced development of regenerative therapies for rare diseases and has gained and used multiple regulatory designations including orphan drug, breakthrough, fast-track, regenerative medicine advanced therapy (RMAT), and advanced therapies medicinal product (ATMP).
Enzyvant currently has research and development offices in Durham, North Carolina.