NuvOx Pharma has completed construction and initiated operation of its GMP production facility for manufacturing its injectable pharmaceutical products at its Tucson, Arizona facility. Construction of the GMP facility was financed by ImaRx Investments, LLC. The facility comprises an 1,800 square foot hard shell exterior space addition to the existing building located at 1635 East 18th Street. A 900 square foot ISO 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. Olivia 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, NanO2TM, 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.”
Jon Saxe, BSChE, JD, LLM, Board Member of NuvOx and former Chairman of the Mobilizing for Quality Task Force responsible for corporate oversight of quality at Hoffman La Roche Inc., said, “I am impressed with the knowledge and commitment to quality of the staff at NuvOx and their capability to successfully execute on their manufacturing program.”
Evan Unger, MD, co-Founder and CEO of NuvOx, added, “We have active Phase IIb programs for NanO2 in ischemic stroke and brain cancer following successful phase Ib/II studies in both of these indications. Our own manufacturing facility allows us to control costs, maintain continuous quality improvement and support our clinical development programs.”
Disclaimer: Certain statements in this release may constitute “forward-looking statements.” Actual events or results may differ substantially as a result of risks and uncertainties facing us. The forward-looking statements are based on current expectations as of the date of these statements. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of future events, new information, or otherwise.
Evan Unger, MD