NKMax America, a biotechnology company harnessing the power of the body's immune system through the development of Natural Killer cell therapies, completed construction on its new 25,000 square foot, state-of-the-art cell therapy manufacturing facility in Santa Ana, California.
The biotech company specializes in both autologous and allogenic Natural Killer (NK) cell therapy utilizing proprietary cell expansion and cell activation technology. This therapeutic technology was developed as a complement to NKMax's first-in-kind in vitro diagnostic test which measures NK cell activity using only one milliliter of whole blood.
According to company officials, the new facility will house the U.S. operations for NKMax and includes administrative offices, a CLIA-certified, CAP-accredited clinical laboratory in addition to cGMP manufacturing capabilities. The flagship facility represents NKMax's commitment to meeting production demands for the SNK cell therapy clinical trials and ultimately for commercial manufacturing.
"The new GMP facility builds on our technical capabilities and rapid progress towards advancing NK cell therapies," commented Stephen Chen, MBA, CTO of NKMax America. "We have designed and built a state-of-the-art facility around our innovative manufacturing processes that enables us to produce clinical and commercial NK cell therapies."
Following occupancy, the company will be taking the next few months to secure the appropriate licensing and wrap up final validation activities before the first official product release, officials said.