Propellant manufacturer Koura (formerly Mexichem) has announced a “multimillion-pound sterling investment” in a new cGMP production facility for Zephex HFA 152a medical propellant at the company’s Runcorn, UK location. The new facility is expected to come online by late 2021, the company said.
According to Koura, “This investment is part of a program to bring Zephex 152a from the laboratory to the patient and will provide a scaling-up in production capacity to meet the increasing demands of customers for high purity, medical grade 152a.”
In February 2020, Koura announced that the FDA had cleared an IND for Zephex 152a and that the company was initiating clinical trials. That news followed a December 2019 announcement by Chiesi saying that it planned to bring a Zephex 152a inhaler to market by the end of 2025.
The company added that “The use of Zephex 152a will bring pMDIs to the forefront of ‘green’ portable inhalation medicine delivery technologies.” The global warming potential (GWP) of HFA 152a is 90% less than that of HFA 134a, and the use of HFA 152a as an MDI propellant has been a major topic of discussion in the industry since at least 2016 when Koura presented data on 152a’s reduced GWP. More recently, the potential switch from HFA 134a to HFA 152a as part of a push toward greater sustainability was a major topic of discussion at DDL 2019.
