Bespak & H&T Presspart announce availability of GMP pilot line for low GWP pMDIs Filling line is on track to supply clinical trial batches utilising climate-friendly propellants HFA-152a and HFO-1234ze

Holmes Chapel, UK, and Blackburn, UK; 8th October 2024 –– Bespak, a specialist inhalation contract development and manufacturing organisation (CDMO), and H&T Presspart, a market leader in the development, manufacturing and supply of inhaled drug delivery components and devices, have announced the availability of a new Good Manufacturing Practice (GMP) pilot-scale filling line for pressurised Metered Dose Inhalers (pMDIs) to be produced using the low Global Warming Potential (GWP) propellants HFA-152a and HFO-1234ze.

This new capability was developed through the partnership between Bespak and H&T Presspart announced in April 2024, which aims to advance the global pMDI industry’s transition to low GWP propellants.

The filling line brings rapid access to small-scale filling capabilities under GMP conditions, which will support development programmes and clinical trials. Due to increasing interest in climate-friendly pMDI production globally, combined with regulatory and legislative pressures, high demand for the service is anticipated. The first batch of clinical material for an undisclosed customer is expected to be manufactured and supplied within a few weeks.

Executives of both Bespak and H&T Presspart gathered at Bespak’s Holmes Chapel site in Cheshire, UK, to mark the occasion. 

Chris Hirst, CEO of Bespak, commented: “The transition to low GWP propellants in pMDIs is gaining momentum around the world. At Bespak, we are proud to be at the forefront of this industry-wide initiative, and proud to partner with H&T Presspart to create further momentum. This new low GWP pilot-scale filling capability addresses the short-term market need for clinical trial supply, and will help pharma companies to advance their low GWP development programmes towards commercialisation. When added to our rapidly expanding low GWP commercial-scale capability, it is clear that we can now offer customers a complete transition pathway.” 

Christian Krätzig, President of H&T Presspart, said: “As the world market leader in pMDI components, H&T Presspart is committed to supporting the industry in transitioning to low GWP propellants. In our partnership with Bespak, we are now leveraging our combined expertise to create the infrastructure needed for small-scale manufacturing with low GWP propellants. The launch of a GMP pilot-scale filling line is an important step forward, and we are excited about future collaborations that will help to create a more sustainable pMDI platform for the next generation.”