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  • Alex Mathers

Project Feature: Nkarta




GMC Commissioning provided cGMP C&Q commissioning services for the Nkarta renovation project on Oyster Point in South San Francisco. The project scope includes the renovation of an existing building at 1150 Veterans Blvd, South San Francisco with buildout of commercial cGMP manufacturing space, laboratory space, and office space.

 

Nkarta is a clinical-stage biotechnology company advancing the development of allogeneic natural killer (NK) cell therapies. By combining its cell expansion and cryopreservation platform with proprietary cell engineering technologies, Nkarta is building a pipeline of cell therapy candidates generated by efficient manufacturing processes, and engineered to enhance tumor targeting and improve persistence for sustained activity in the body.

 

With plans to double their employee count over the next year and a half, Nkarta needed more office and research-and-development space. The new Oyster Point building hosts historical research and cell therapy manufacturing - expanding the effective use of cell therapies in patients which in return will accelerate product timelines. Products include NKX-101, which targets acute myeloid leukemia.

 

GMC Cx commissioned the new Nkarta Clean Rooms, Cold & Freezer Rooms, Plumbing, Process, HVAC & Controls Systems, and Electrical Systems. GMC Cx provided and executed leveraged GDP protocols for IQ/OQ documentation of direct impact systems. Commissioning and Qualification (C&Q) are early phases of the validation life cycle of manufacturing facilities, utilities, systems and equipment. C&Q precedes the manufacturing of products at scale, and subsequent process validation.

 

Collaboration was the key to project success and a fundamental aspect of GMC’s success project delivery.  We strive to unite the team behind the common goal of project quality.  Our team was involved from start to finish, not as a sideline player, but an invested stakeholder in the project.  We took pride in delivering this high quality, efficient, building to Nkarta. 

 

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