Bespak & Medicines Evaluation Unit Collaborate to Accelerate Clinical Trials on Climate-Friendly Inhalers

Bespak and The Medicines Evaluation Unit (MEU) recently announced a collaboration to further accelerate the pharmaceutical industry’s transition from existing pressurized Metered Dose Inhaler (pMDI) formulations to climate-friendly alternatives utilizing low global warming potential (GWP) propellants.

The partnership will align expert teams from the two organizations 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 utilisze 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, said “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, added “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.

Bespak is a global contract development and manufacturing organization (CDMO) focused on inhaled and nasal drug delivery devices and drug-device combination products. Bespak develops and manufactures finished pharmaceutical products, as well as being a leading global supplier of drug delivery devices and componentry to the pharmaceutical industry. 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, and also specializes in the industrialization and high-volume manufacture of complex dry powder inhaler (DPI) devices.

Headquartered in Holmes Chapel, UK, the company’s service offering spans early-stage feasibility, analytical services and product development, from pilot-scale, through to clinical supply and commercial-scale drug product fill-finish, device and component manufacturing. More information: www.bespak.com

The Medicines Evaluation Unit (MEU) Ltd is one of the UK’s leading contract research organizations, a facility where commitment to excellence is paramount. The MEU is recognized as one of the leading sites to undertake clinical trials in respiratory conditions, including asthma, COPD, IPF, CF and NCFB, having carried out over 350 studies in this area. MEU’s renowned team of respiratory physiologists has extensive experience in lung function testing, novel measurement methodologies and inhaled drug administration, having received advanced training from the Association for Respiratory Technology and Physiology (ARTP). Study designs include bronchial and nasal challenge (viral, LOPS, allergen, methacholine, cough), respiratory physiology (spirometry, FeNO, oscillometry, plethysmography, gas washout testing, gas transfer), respiratory sampling (sputum, breath condensate, VOCs, nasal epithelium, nasal secretion) and exercise challenge methodologies (CPET, 6MWT, shuttle walk).