Simon Gardner, Business Development Director
Change is in the air: preparing for the transition to low GWP propellants
Every day, around the globe, pressurised metered dose inhalers (pMDIs) are saving the lives of those with asthma and other respiratory diseases, such as COPD. For decades, this key technology for the delivery of essential medicines has relied upon hydrofluoroalkane (HFA) propellants. However, due to their high global warming potential (GWP), changing legislation — as well as the ESG goals of individual companies — is encouraging reduced use of HFA propellants
At Bespak, we are seeing firsthand that a growing number of pMDI developers are seeking to transition from existing propellants to the low GWP alternatives of the future — HFA-152a and HFO-1234ze — as quickly as possible. By committing early to this shift, developers will not only meet regulatory demands, but also ensure the availability of life-saving medicine as the industry navigates the transition process, and for many years to come. A healthy pMDI industry, individual companies’ business success, and clinical outcomes for patients all depend upon the timely actions of the pharmaceutical industry working in partnership with regulators and the supply chain.
To support developers through the challenges of transition, we’re investing early in capabilities to provide dependable services for both new low GWP propellants. Not only have we taken delivery of a brand-new state-of-the-art filling line to manufacture at commercial scale with HFO-1234ze – the first CDMO to make this commitment – we will also be fully capable to supply clinical trial material with both new propellants before the end of 2024. Our product feasibility and development laboratories are already fully equipped to develop pMDIs with both propellant candidates.
Not content with this progress, we have invested in additional capacity, engineered to manufacture at commercial scale with HFA-152a. This new high-speed commercial filling line for pMDIs at our Holmes Chapel, UK, site, will be installed during 2026 and qualified to supply commercial product by 2027. This is an exciting step in facilitating the shift to greener alternatives for customers. However, low carbon pMDI manufacturing capability in the industry is limited. Companies looking to secure their manufacturing capacity for pMDIs utilising either HFA-152a or HFO-1234ze should do so today or risk being left behind in a rapidly changing market.
Facing uncertainty in an evolving regulatory landscape
The change to low GWP propellants has been seen across the world in many sectors. Under regulations, such as the EU F-gas Regulation ((EU) No 517/2014, retained in the UK following exit from the EU), and the US AIM Act (American Innovation and Manufacturing (AIM) Act of 2020), the pMDI industry has enjoyed certain protections. However, those protections are starting to fall away as low GWP propellants come to market and new regulation encourages their adoption by all sectors – including the highly regulated pharmaceutical sector.
Many companies may feel uncertain about what they need to do next. Some may wonder whether they even need to make the shift towards greener propellants at all. But the direction of regulatory change is clear: in the next few years, every pMDI, certainly in Europe and the US, will transition to low GWP propellants.
There should be no expectation that the pace of regulation will slow down and, without a clear strategy, companies risk being left behind as the market moves forward. This can feel like a threat to business, but by offering the right services and support, we want customers to see the changing landscape as an opportunity for growth and success. However, this means taking those next steps towards low GWP propellants sooner rather than later.
Key considerations for a successful transition
When transitioning to greener propellants, there are many factors that need to be considered. From making big strategic decisions about how to participate in the future market, to establishing robust supply chains, companies will need support to formulate their plans for the future. This includes deciding whether they want to replicate their existing portfolio in low GWP propellants or develop new formulations, which of the low GWP propellants to select, and how to mesh these decisions with their existing inhouse or outsourced manufacturing operations and the wider supply chain. Time is running out to make these decisions, so working with experts who understand the industry and can offer a myriad of options is vital when charting the best way forward through this evolving landscape.
Investing in facilities to meet demand
Making the decision to begin transitioning to green propellants is not an easy one – but making that decision now is important. Here at Bespak, we have the right people, the right capabilities and the right approach to help companies deal with the challenges of transitioning — and deliver their plans. For those who decide to develop low carbon pMDIs, Bespak has invested in laboratory, clinical scale and commercial manufacturing capabilities. And we will continue to invest so we can support our customers through any future changes.
As legislation changes and the move to a more sustainable future drives us all forward, the adoption of green propellants will only increase in velocity. However, there is a very real risk that current low carbon pMDI manufacturing capacity will not be able to keep up with growing demand. This scarcity could impact not only business continuity, but also the availability of life-saving medications for those that need them most.
To help alleviate this scarcity and to support our customers and their patients, we have invested in both clinical-scale and high-speed commercial filling equipment for low carbon pMDIs in our facility in Holmes Chapel, UK. Our newest line will be able to handle both low GWP propellants, meaning we will be well positioned to support customers as the market evolves. Commercial batches will begin production by Q4 2027 and, due to high demand, we expect the capacity of the new line to be fully reserved by the end of 2024, based upon current customer interest and commitments.
Collaboration for a complete service
The transition to low GWP propellants will require significant effort. At Bespak, we’re committed to the change and have invested significantly in our own capabilities to enable the transition. However, our industry relationships mean we can offer even more solutions and a fuller service to customers.
We’re proud to collaborate with OzUK on product development, The Medicines Evaluation Unit on clinical studies, and with H&T Presspart on enabling the manufacture of clinical batches. Those partnerships mean we can now deliver the services customers need.
Facilitating a more sustainable future
The next few years may hold challenges and uncertainties as the pMDI industry shifts towards low GWP propellants. But through investment, innovation and partnerships, Bespak has the capabilities to guide companies to a greener future. Those looking to secure low carbon pMDI manufacturing supply—whether they choose HFO-1234ze or HFA-152a— should reach out today before capacity is filled.
Take a step towards a more sustainable future and discover how we can help you breathe a little easier in the ever-changing pMDI landscape.
