Kindeva has officially opened its new UK headquarters and manufacturing site in Loughborough. The 150,000-square-foot facility is designed to focus on metered-dose inhalers (MDIs), including the development and analysis of next-generation, more environmentally friendly propellants. Inhaler propellants are thought to contribute around 0.03% of total global greenhouse gas emissions – and also represent 3% of the carbon footprint for the UK’s National Health Service.
We spoke with Craig Sommerville, Senior VP, MDI, at Kindeva about the challenges of scaling up for new propellants, the regulations in this area, and what a more sustainable future could look like.
What challenges did you face in scaling up operations to handle next-generation propellants?
After the CFC transition about 20 years ago, the industry standard moved to a hydrofluoroalkane propellant called 134a, which – although not O-Zone depleting – still has high-global-warming-potential (GWP). Since then, new regulations have come in, including the Kigali Amendment, which sets out pathway for phasing out existing high-GWP propellants, such as HFA134a.
There are two main alternatives for replacement propellants. Kindeva is building capability for both, so that we can be ambidextrous for our meter-dose inhaler (MDI) business. One propellant is classified as flammable so we have already invested in intrinsically safe, so-called ATEX-rated filling lines to manage that risk.
Is there a timeline for the abolition or reduction of high-GWP propellants?
It varies by country and by market. Several large pharma companies have set their carbon reduction targets with a focus on the end of this decade, so we see 2030 as a key milestone, from a customer and regulator viewpoint. In some regions, there’s talk of a complete ban by then, but most likely there will be a transition period with increasing restrictions between 2030 and 2050. In the US, California, for example, is taking quite a strong stance. The EU is also moving firmly toward prohibiting the use of high-GWP propellants and is adopting a phase-down approach with the implementation of quotas and tariffs. To put it in context, the Kigali Amendment – which was agreed in 2016 – is an amendment to the Montreal Protocol of 1987. The Montreal Protocol originally set the phase-out of CFCs, and Kigali built on that framework to tackle hydrofluoroalkanes (HFAs) and their high global warming impact. So, the shift has been a long time coming.
When it comes to sustainability, do you mainly react to legislation, or is there another driving force?
Legislation is certainly a driving factor which will influence market reaction, but it’s better to be proactive to anticipate where the market will shift. We’ve looked ahead to see where the market and macroeconomics are headed, and it’s clear that regulation and societal demands will drive a shift to next-generation propellants. As that happens, the availability of high-GWP propellants will reduce, so sourcing will become more expensive and difficult. So, from both a sustainability and a financial perspective, early adoption makes sense. For companies that want to be successful in the future, being ahead of that curve is really important.
And it’s not something that can be done overnight. Visitors to our new site were able to see how early-stage activities including formulation development, analytical development, scale-up, industrialization, regulatory approvals, and clinical manufacture eventually lead to full-scale commercial manufacturing and approval. This is a long process and the lead times for specialized equipment can also be long.
Part of the role of our business unit at the Loughborough site is to think on a three-, five- or even ten-year time horizon; anticipating regulatory changes, anticipating what customers will need, and building a supply chain that’s ready to meet those requirements.
Is there room for further improvement in MDIs?
An MDI comprises several components including canister, valve, actuator, dose counter, propellant, and the API itself. You may also have some solvents, but ultimately there are a fairly limited number of levers to pull – and since these devices are well understood and loved by patients, we wish to retain that value to treat respiratory conditions. Many MDIs exist to provide rescue for patients during acute asthmatic exacerbations. For that purpose, the propellant is essential; it provides the necessary force to deliver the API into the body where it is needed – the lung.
All of this doesn’t mean that improvements can’t be made, of course. But when an established device works for its intended purpose, there can be a “if it’s not broken, don’t fix it” mentality. A product that switches to a next-generation propellant will be treated as "new’" from a regulatory and development perspective. But at the same time, we want patients to experience no change in the way they use their medicine. The patient experience should be the same, the impurity profile comparable, and the dose delivered by each unit should remain the same as with the old propellant.
How will the Loughborough site continue to grow?
We’re positioning Loughborough as Kindeva’s Center of Excellence for MDIs. It brings together our analysts, R&D teams, commercial staff, and supply chain people – with the goal of speeding up the entire drug development and commercialization process.
We’re already seeing increased customer interest in securing capacity on our new lines. We also have the vision of increasing capacity to exceed 100 million units per year.
Our aspiration is to grow significantly. Over the next 10 years, we’re probably looking to double the number of people on this site. The fact that we’re part of a campus with other life sciences companies creates a real centre of gravity and makes the location very attractive.
We’re also surrounded by several universities, which strengthens the talent pool. But there’s still work to do in attracting, retaining, and developing people. Our values are strong, and STEM has a strong presence in the local environment, but we’re working to put ourselves front and centre – through our brand, our storytelling, and by highlighting how we ultimately help improve patient outcomes.
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