Richard Turner, Head of Business Development
Risky business: how decision delay could disrupt your transition to low carbon pMDIs
The Kigali Amendment to the Montreal Protocol aims to gradually reduce the production and consumption of hydrofluorocarbons (HFCs) — powerful greenhouse gases that contribute to climate change. Within the pressurised Metered Dose Inhaler (pMDI) industry, this means a phase down of HFC propellants and the rise of alternatives with low global warming potential (GWP).
The transition towards low GWP propellants — specifically HFA-152a and HFO-1234ze — requires strategic decision making and a good understanding of the evolving market, as well as the expertise to formulate products in a timely manner. Availability of manufacturing capacity for low GWP pMDIs is limited and, as demand grows, some developers may find themselves suddenly left behind. Delayed or hesitant decision making could result in a strategy that is misaligned with available capacity, and unable to meet patient needs.
To keep up with these legislative changes and ensure the continued supply of essential medicines, some developers are already securing manufacturing capacity well in advance of the timelines specified by the Kigali Amendment. The phase out of HFC propellants will likely be driven by the supply chain, not regulation, and it may arrive sooner than expected.
Accelerating our customers’ low GWP journey
Switching to greener propellants can seem daunting. After all, making the correct strategic decisions the first time around is vital for success — not only from a business standpoint but also to ensure the availability of safe and efficacious solutions for patients.
It’s important, therefore, that developers can trust our knowledge, know-how and experience to execute an efficient change and guide them through a changing landscape. Already, some of our customers are recognising the reality of the timelines the industry is facing, and we’ve helped them accelerate their programmes significantly.
Not only are we able to provide our own insights and capabilities, but our industry collaborations allow our customers to access different levels of knowledge and aspects of the development, clinical trial and commercialisation pathway that will help them succeed in an evolving market.
Fast-tracking a more sustainable future
In order to achieve market approval, customers need to have development expertise and manufacturing capacity they can rely on, underpinned with deep insight into the market. Here at Bespak, we are uniquely positioned with end-to-end capability to ensure the successful commercialisation of low GWP pMDIs. We not only supply the trusted Bespak valves – approved on more products in more markets than any other valve, and now optimised to perform with the new generation of greener propellants — we also have a laboratory equipped to develop pMDIs with both of the low GWP propellant options, manned by our expert development team.
Another way in which we are supporting the industry is through our investment in a new high-speed commercial filling line for climate-friendly pMDIs in our facility in Holmes Chapel, UK. In addition to previous expansions, this new line will provide manufacturing capacity for pMDIs utilising low GWP propellants, enabling customers to continue delivering life-saving medicines as the market evolves. However, availability won’t last long, with the line capacity expected to be reserved during 2024, and ready for batch manufacturing in Q4 2027.
Starting the transition to green propellants today
A significant risk to developers transitioning to low GWP propellants is delayed decision making. The shift is expected to happen in advance of mandated timelines, and being caught off guard may mean the sacrifice of an early market position and market share. Securing timely manufacturing capacity for both clinical trial and commercial supply is crucial to success. Here at Bespak, we can help. With the capacity of our newest manufacturing line expected to be reserved over the coming weeks, we encourage customers to talk to us to secure a solution. Reach out and discover how you can accelerate your low GWP transition with us.
