Oz-UK, the Chippenham based contract research organisation dedicated to providing pressurised metered dose inhaler (pMDI) and liquid aerosol research and development (R&D), has announced the installation of its new low-GWP (global warming potential) manufacturing line to meet global needs for pMDI investigation ahead of the Kigali Amendment deadline.
The company said the move tackles the pharmaceutical industry's concern for phase-down of the use of fluorinated gases (F-gases) by 2047, stipulated by the Kigali Amendment.
F-gas regulations have a significant impact on the market for inhalation products and switching to propellants with a lower GWP is a commercial imperative for pharmaceutical manufacturers, it went on to say.
The new low-GWP line – funded in part by Oz-UK and in part by grants from Wiltshire Council through the UK Government’s Prosperity Funds – is located in one of Oz-UK’s two custom-built facilities in Chippenham, Wiltshire, and will be operational by July 2024.
The new low-GWP line will add to the current client development services for low-GWP solution and suspension pMDI development programmes. The line will manufacture pMDIs containing HFO-1234ze and HFA-152a propellants and will allow 2.5 – 10-kilogram batches to be manufactured.
As the pharmaceutical industry attempts to develop viable alternatives, these need to be trialled in new formulations and new devices to comply with the phase-down, said Oz-UK.
Currently, R&D is focusing on moving away from the two most common HFA propellants, 134a and 227ea, and towards low-GWP HFA and HFO propellants, such as 152a and 1234ze, both of which the new Oz-UK manufacturing line is designed to accommodate.
Low-GWP alternatives exhibit different physiochemical properties to their predecessors, which can impact the stability and spray formation associated with the formulation.
Therefore, significant amount of R&D is needed to support the transition to next generation propellants for pMDIs, according to the company.
Oz-UK, which already offers formulation development services to the pharmaceutical, biotechnology and cannabinoid industries, is rapidly investing in its facilities to keep up with global demand for R&D, formulation and pilot production capabilities.
Dr. David Lewis, director of Oz-UK, said: “Development of inhalation products is limited by the difficulties of R&D in a pressurised environment and the propellant propulsion challenges of aerosol science. Our years of experience in this market mean that Oz-UK is uniquely positioned to support pharma at speed, with the facilities needed to undertake the R&D, formulation, and pilot testing of new pMDIs.
"We are already working on technical transfer and intellectual property (IP) transfer for a number of global businesses who have carried out this work with us, including Recipharm who also announced a collaboration with Oz-UK for its initiative to accelerate the development and manufacture of 'green' pMDIs. The introduction of our new low-GWP line will enable more companies to undertake these projects more quickly as the deadline for F-gas phase-down approaches.”
Oz-UK Ltd announces new low-GWP manufacturing line installation
