Relationship will provide pharmaceutical industry with fast route to clinical evaluation of low GWP pMDIs

Bespak, a leading contract development and manufacturing organisation (CDMO) focussed on orally inhaled and nasal drug-device combination products, and The Medicines Evaluation Unit (MEU), one of the UK’s leading contract research organisations undertaking clinical trials in respiratory conditions, announced today a collaboration to further accelerate the pharmaceutical industry’s transition from existing pressurised Metered Dose Inhaler (pMDI) formulations to climate-friendly alternatives utilising low global warming potential (GWP) propellants.

The partnership will align expert teams from the two organisations who will share knowledge and combine resources in order to fast-track time to clinic, and increase the throughput of low GWP pMDIs moving through clinical evaluation. Designed to service the increasing demand from pharmaceutical companies transitioning their inhaler portfolios to utilise the new generation of greener propellants, the collaboration will leverage Bespak’s clinical supply capabilities at its Holmes Chapel site to manufacture pMDIs containing the new propellants (HFA-152a and HFO-1234ze), for use in clinical studies to be conducted at the MEU. The collaboration also includes MEU’s Regulatory consultancy for clients to access as part of a package of services.

The companies will focus their activities with their teams working in close geographical proximity at their sites in the North West of England, well-known for its pMDI knowledge base and cluster of specialist pMDI companies such as Bespak.

Chris Hirst, CEO of Bespak, commented: “We are committed to leading the transition to low GWP propellants in pMDIs, and this collaboration with the highly respected MEU provides an accelerated route for our clients into clinical trials with more sustainable inhalers. At Bespak, we believe in working together across the industry to achieve a smooth transition that not only helps combat climate change, but also safeguards patient access to the familiar pMDI inhaler format.”

David Rogers, CEO of MEU, said: “We are pleased to partner with Bespak to offer a fast pathway to the clinic for more sustainable inhalers using low GWP propellants. As two companies who have experience of the last environmentally-driven transition in pMDIs, we are pleased to bring together our services in a simplified pathway. Our joint aim is to enable more companies to enter this next phase in the development of greener inhalers, to benefit both patients and planet.”

The MEU is at the forefront of testing new climate-friendly inhalers to ensure they are safe and effective for large populations worldwide, and to support the transition towards low GWP propellants in pMDIs currently in development. MEU led the testing of ozone friendly CFC-free inhalers that replaced CFC containing inhalers as a result of the Montreal Protocol on Substances that Deplete the Ozone Layer, adopted in 1987, and has already successfully conducted clinical studies into the investigation of both of the new low GWP propellants in development.

Bespak’s Holmes Chapel site has a long history in the development, scale-up and clinical and commercial supply of inhalers going back to the 1960s. This most recent announcement builds upon Bespak’s recent news including its spin-out from the Recipharm Group to create an independent company focused on inhaled and nasal drug-device combination products; its significant investment in commercial-scale and pilot-scale filling equipment for the manufacture of pMDIs using low GWP propellant HFA-152a at its Holmes Chapel site; and the site’s landmark milestone last year as it became the first CDMO to manufacture a pMDI at commercial scale with HFO-1234ze, a near-zero GWP propellant.