The leases, which were disclosed on the same day, reflect the progress of the two companies and the need to start preparing to produce the larger quantities of cell therapies that will be required as their assets move through the clinic and onto the market.
Seattle-based Sana, having raised US$588m in an initial public offering before entering the clinic, has taken out a lease on a site in Fremont, California. The plan is to develop a 163,000 square foot production facility to support late-stage clinical development and early commercial sales, while working with contract manufacturers to get assets into human testing next year.
Sana’s desire to secure capacity for the production of late-stage development and beyond while still in preclinical development is indicative of the ambition of the biotech and the challenges cell therapy developers are facing as they try to scale up their operations.
“Manufacturing remains a key bottleneck to the development and broad accessibility of cell- and gene-based medicines,” said Sana CEO Steve Harr. “This facility is a key component in enabling our aspirations to rapidly innovate, consistently manufacture, and scale production of these medicines.”
In financial regulatory filings, Sana has called owning its own manufacturing facility “a key” to its strategy, while noting that it has limited experience in the area and that “manufacturers of ex vivo cell engineering products often encounter difficulties in production, particularly in scaling up, scaling out, validating initial production, ensuring the absence of contamination, and ensuring process robustness after initial production.”
T cell, viral vector and pluripotent stem cell production
Sana is designing the Fremont facility to support allogeneic T cell, viral vector and pluripotent stem cell production, reflecting the breadth of the portfolio it is putting together to treat cancers and other diseases.
The Nkarta lease covers a 88,000 square foot facility in South San Francisco. Nkarta has leased the site to facilitate the scale up of its off-the-shelf natural killer cell therapies to support clinical trials and commercial sales.
News of the lease comes shortly after Nkarta completed construction and qualification of a 2,700 square foot facility. The existing facility is making supplies of CD19 cell therapy NKX019 and will take over the production of NKG2D prospect NKX101 in the future.
As those programs progress, Nkarta expects to need additional capacity. Taking out the lease on the site in South San Francisco positions Nkarta to grow in line with its production requirements.