Respira Technologies, Inc. announced , its partnership with the Plough Center for Sterile Drug Delivery at the University of Tennessee Health Science Center to execute aseptic drug product handling and cartridge filling to support the companies planned IND submission to the FDA and to prepare for human clinical studies.
LOS ANGELES, March 22, 2022 /PRNewswire/ -- Respira Technologies, Inc. (Los Angeles, CA) announced today, its partnership with the Plough Center for Sterile Drug Delivery at the University of Tennessee Health Science Center to execute aseptic drug product handling and cartridge filling to support the companies planned IND submission to the FDA and to prepare for human clinical studies.
Respira Technologies, Inc. is pursuing FDA authorization by CEDR as the first inhalable prescription smoking cessation therapy. The Plough Center, a non-profit sterile drug delivery organization, provides best in class pharmaceutical drug product services to early-stage biotech and pharma companies advancing technologies that can have a significant impact on our society.
Mario Danek, Respira’s CEO stated, “The Plough Center allows Respira to achieve compliance with FDA’s standards for aseptic drug product handling and also gives us access to industry leading capabilities so we can be successful in our mission to end the world’s leading cause of preventable death and disease.”
Dr. Harry Kochat, Director of Operations at the Plough Center and Member of the FDA CEDR’s Panel on Sterile Drug Manufacturing and Technologies, stated, “The Plough Center is excited to partner with Respira’s team and we are committed to supporting them, their important mission and their plans to bring this life-saving combination drug product to market.”
“Through the Plough Center, we in academia can support our partners in the private sector in advancing technologies that neither sphere of influence can expeditiously do without the other. We hope this model for innovation becomes the norm for advancing life-changing interventions for the benefit of mankind globally,” Dr. Kennard Brown, Chief Operating Officer, Executive Vice Chancellor of UTHSC, and Executive Director of Plough Center said.
The RespiRx™ is a combination device where the sterile drug product is filled aseptically in a disposable cartridge which also includes the proprietary aerosol generating engine. Maintaining sterility of the drug product and effectively complying with FDA’s container closure requirements requires best in class capabilities. By adding the Plough Center to Respira’s network of world class partners, Respira will be able to satisfy FDA’s combination product compliance requirements and support sterile manufacturing through all phases of human clinical studies.
Respira plans to submit its IND in 2022 and pending FDA approval is preparing for Phase I human clinicals in early 2023.
About Respira Technologies, Inc.
Respira is based in Los Angeles, CA and was founded by CEO Mario Danek in 2018 to build cutting-edge drug delivery platforms that improve patient outcomes through superior device technologies.
The RespiRx™ is the first orientation-agnostic, portable VMN device that effectively operates in any position held by the patient. Respira sees significant opportunity to utilize its drug delivery technologies to improve the treatment of Asthma, COPD, Vaccine Delivery, Pain Management, and several generic as well as select investigational new drugs with safe and effective inhalable drug delivery mechanisms that only the RespiRx™ can deliver.
Respira is backed by venture firms: Blue Ledge Capital, Compass Rose Asset Management, DG Ventures, Evolution VC Partners and Poseidon Asset Management.
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SOURCE Respira Technologies, Inc.
