Terra Universal completes ISO Class 5 cleanroom for injectables

The NuvOx Pharma facility features a 1,800 sqft hard shell exterior space addition with a 900 sqft ISO Class 5 cleanroom is housed within

NuvOx Pharma has completed construction and initiated operations at its new GMP production facility. The facility is for manufacturing its injectable pharmaceutical products in Tucson, Arizona.

The facility features a 1,800 sqft hard shell exterior space addition to the existing building. A 900 sqft ISO Class 5 cleanroom is housed within the exterior space.

Olivia Longacre, Chief Operating Officer of NuvOx, oversaw construction of the exterior space and installation of the cleanroom. Longacre said: "This same ISO 5 modular cleanroom, manufactured by Terra Universal, has been successfully used by large and small pharmaceutical companies to manufacture pharmaceutical products commercially."

"It is our goal to manufacture our lead product, NanO2, for pivotal clinical trials and commercial supply after FDA approval. We have invested in our Quality Management System intended to meet all FDA regulatory requirements," Longacre added.

Evan Unger, MD, co-Founder and CEO of NuvOx, explained: "Our own manufacturing facility allows us to control costs, maintain continuous quality improvement and support our clinical development programmes."

Construction of the GMP facility located at 1635 East 18th Street was financed by ImaRx Investments.

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