Successful FDA inspection at Gerresheimer Peachtree City, USA

Vero Biotech’s GENOSYL Delivery System / Vero Biotech’s first tankless inhaled nitric oxide delivery system

Einwegkassette des GENOSYL tanklosen Inhalationssystems für Stickstoffmonoxid / Cartridge of the GENOSYL tankless inhalation system for nitric oxide

The Gerresheimer subsidiary in Peachtree City, USA, was named an approved “Contract Manufacturer for VERO Biotech’s GENOSYL Delivery System (DS), drug substance intermediate” for the disposable cassette of the company’s third generation of the first tankless inhaled nitric oxide delivery system. As part of the product’s approval on the American market, the entire manufacturing strategy was examined by the United States Food and Drug Administration.

Important new development in clinical use

The FDA inspection took place from November 17, 2022 to December 12, 2022 at the Gerresheimer facility in Peachtree City. During this time, production at the facility was inspected by drug and device Consumer Safety Officers, who evaluated the management system and production process for disposable cassettes, from incoming raw materials to finished products.

This inspection was a key step for the approval of the third generation GENOSYL Delivery System (DS). The approval presents an important new development in the clinical use of inhaled nitric oxide, and the pent-up demand for this third generation innovation demonstrates its increasing value to the acute care community.

Numerous benefits for patients and medical professionals

GENOSYL Delivery System (DS) for inhaled nitric oxide was approved by the U.S. Food and Drug administration in December 2019 and was the first tankless delivery system for inhaled nitric oxide. Inhaled Nitric Oxide dilates pulmonary blood vessels and may be used to improve oxygenation in neonates with hypoxic respiratory failure and pulmonary hypertension.

Unlike tank-based systems, GENOSYL DS generates and delivers iNO at the bedside using a small disposable cassette. This eliminates the need for hospitals to manage large, cumbersome tanks and helps to simplify clinical workflow. The recently approved third generation GENOSYL DS also includes an innovative dual-cassette design and secondary adaptive sensor technology to further optimize patient care.

About GENOSYL

Indication

GENOSYL (nitric oxide) gas, for inhalation, is indicated to improve oxygenation and reduce the need for extracorporeal membrane oxygenation in term and near-term (>34 weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension in conjunction with ventilatory support and other appropriate agents.

Important Safety Information

– GENOSYL is contraindicated in the treatment of neonates dependent on right-to-left shunting of blood.
– Abrupt discontinuation of GENOSYL (nitric oxide) gas, for inhalation may lead to worsening oxygenation and increasing pulmonary artery pressure.
– Methemoglobin levels in the blood increase with the dose of nitric oxide; following discontinuation or reduction of nitric oxide, methemoglobin levels return to baseline over a period of hours.
– Methemoglobin, NO2, and PaO2 should be monitored during nitric oxide administration.
– In patients with pre-existing left ventricular dysfunction, GENOSYL may increase pulmonary capillary wedge pressure leading to pulmonary edema.
– The most common adverse reaction is hypotension.
– Nitric oxide donor compounds may have an additive effect with GENOSYL on the risk of developing methemoglobinemia.
– GENOSYL must be administered using a calibrated GENOSYL Delivery System. Only validated ventilator systems or nasal cannulas should be used in conjunction with GENOSYL.