Israeli cell technology company Pluri has expanded its cell-based product operations in a bid to support other companies with their development plans, announced Pluri’s CEO Yaki Yanay.
In an exclusive interview with Pharmaceutical Technology, Yanay shared updates on the company’s cell-based product pipeline and discussed its manufacturing strategy.
The cell-based technology company launched its contract development and manufacturing division, PluriCDMO, in January 2024. Through this, the company is sharing its knowledge base, technology and facilities with other businesses to develop stem cells, induced pluripotent stem cells, exosomes and immunotherapeutics.
Since the inauguration of its manufacturing branch, Pluri has announced a partnership with Israeli biotech Remedy Cell to manufacture its idiopathic pulmonary fibrosis treatment, RC-0315, as per a March 2024 press release.
Over a decade ago, Pluri chose to take on the bulk of its manufacturing for its pipeline, to streamline its operations.
“We took a strategic decision over a decade ago, that if we're serious about bringing cell therapy to market, we should better control manufacturing,” explains Yanay.
He says that for cell and gene therapy biotechs to succeed in the later stages, more companies need to pay attention to the smaller details within their manufacturing practices.
Pluri has more than 140 validated patents protecting different aspects of its cell culturing and manufacturing processes for cell-based products. Yanay says that due to the company's investment in the biotechnology space, it has reached the point where it can produce stem cell treatments for over 20,000 patients from a single placenta.
Pluri is currently working with the National Institutes of Health (NIH) and the US Department of Defense (DOD) to develop PLXR18 (avoplacel), a placenta-derived cell therapy, to countermeasure acute radiation syndrome.
Acute radiation syndrome is a condition caused by “irradiation of the entire body by a high dose of penetrating radiation in a very short period of time, as per the Centers for Disease Control.
The US Food and Drug Administration (FDA) granted the therapy an orphan drug designation for acute radiation syndrome in October 2017. The cell-based product, which is also being developed in a Phase II study for haematopoietic recovery following haematopoietic cell transplantation (HCT), received an orphan designation the aforementioned indication in June 2020.
