Bespak & H&T Presspart Announce Availability of GMP Pilot Line for Low GWP pMDIs

Bespak, a specialist inhalation contract development and manufacturing organization (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 pressurized 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, said “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 programs toward commercialization. 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, added “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.”

Bespak is a specialist global contract development and manufacturing organization (CDMO) solely focused on the inhaled and nasal drug delivery industry. It develops and manufactures inhaled and nasal drug products, drug delivery devices and components for the global pharmaceutical market. Headquartered in Holmes Chapel, UK, Bespak provides a specialist, fully integrated service to support customers from early-stage feasibility, analytical and formulation, product development and clinical supply, through to full-scale cGMP batch production.

With a long history in the development and commercial supply of pressurized Metered Dose Inhalers (pMDIs), Bespak supplies a major proportion of the world’s pMDI dosing valves and actuators. Built on established expertise but ready for the future, Bespak is a long-term innovation partner committed to driving sustainability in the industry.  The company has both established capacity and ongoing expansions to enable the manufacture of pMDIs with low Global Warming Potential (GWP) propellants, making it well positioned to lead the green pMDI transition. For more information, visit www.bespak.com.

H&T Presspart is a market leading manufacturer of drug delivery devices and components with more than 50 years’ experience and enjoys a worldwide reputation for competence, quality, and innovation in the pharmaceutical market. As a global leader in the Inhalation market, H&T Presspart provides integrated solutions to support the industry transition to low GWP propellants. Combined with a wide portfolio of components and device solutions, H&T Presspart offers product development and analytical services to accelerate route to market of customers’ drug delivery programs. As one of the first in the industry, H&T Presspart unveiled an investment to establish a filling facility equipped to fill metered-dose inhalers with low GWP propellants in 2022. H&T Presspart has 4 European manufacturing sites in Germany, Spain, Switzerland, and the UK and has sales representation in China, India, the US, and Uruguay. For more information, visit www.presspart.com.