Olivia Friett, editor of European Pharmaceutical Manufacturer spoke to Markus Laubscher, head of pharma at Orbia Fluor & Energy Materials for the 30th anniversary of Zephex.
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For over 30 years, Zephex has served a significant proportion of the global pDMI market. So, what do you see as the key factors behind that?
To better understand this, we carried out a number of customer surveys with organisations within the respiratory pharma space as well as having on-to-one discussions to hear directly from them. The feedback that consistently came back was, firstly, that there is absolutely no compromise on quality, with many saying our propellant is the highest quality there is. I believe this is the key differentiator, because quality must be of the highest standard for any medically regulated product.
The second factor is the strong technical and regulatory support our team provides. Whenever customers face issues - whether it’s loading and unloading a product, or questions about irregularities - there is always someone at the other end of the line to help.
This support extends all the way through the regulatory procedures required to bring new products to market.
All of these things are very highly valued by our customers, as shown in the survey feedback analysis, and I believe they are the main reasons behind the long-term success of the brand and also the business.
So how would you compare Zephex 152a's performance compared to other propellants?
The main reason for the development of Zephex 152a was its 90% reduction in carbon emissions compared to the most widely used product currently, Zephex 134a. Over the past 15 years, we have invested heavily in R&D to identify the most promising alternative to existing propellants on the market.
Zephex 152a emerged as the most balanced candidate because its global warming potential (GWP) is much lower than existing propellants, toxicology is not an issue, and manufacturing costs are manageable. Of course, there are downsides to it as well - it is a flammable propellant, so safety measures must be in place for its storage and use in MDI manufacturing. With the incorporation of ATEX approved facilities, this factor can be managed well.
That said, we believe this propellant is currently the best available alternative. We have been working closely with our partners to take all the necessary steps to ensure it is both safe and accessible for pharmaceutical companies making the transition; a move that many major pharmaceutical organisations are already undertaking.
So, from a patient perspective, the new propellant is neither better nor worse - it is different.
It has different physical properties that must be considered when reformulating MDIs. For example, they interact differently with valves, so some minor adjustments are needed, but these have been embraced and actioned by our valued partners across the MDI value chain.
Now that all challenges have been addressed and resolved as an industry, we are close to being able to bring these new MDIs to the market.
Recently, there has been a new facility in Runcorn. Could you tell us a bit about that?
We have just celebrated the 30th anniversary of our Zephex brand, marking 30 years of supplying the respiratory pharma market with medical propellants.
The journey started in 1995, when we developed and built a purification plant for the propellant, Zephex 134a, which is now the most widely used medical propellant around the world. However, this propellant has a high GWP, and regulatory measures, such as the Montreal Protocol and its Kigali Amendment, have been introduced to phase down higher GWP hydrofluorocarbons. As a result, the industry has been looking for low GWP alternatives - and this has been our focus too.
This is why in 2022, we opened a small-scale facility in the North West of England for the development of a next-generation propellant. Then, in November last year, we broke ground on a large-scale production facility, which is currently under construction and will be operational in the second half of 2026.
Are you opening a new facility due to demand?
What we are seeing is a transition from the existing propellant to the new one. While overall demand for pMDIs and medical propellant remains broadly stable, we need to expand our capacity for the new propellant to commercial scale.
Over the coming years, demand for the existing propellant, Zephex 134a, will gradually decline. By building the new 152a facility, we will have significantly more capacity, enabling a smooth, gradual shift from one propellant to the other. That said, we expect 134a to remain in use for many years to come.
Different regions around the world are at different stages in the transition. We will continue to supply the existing propellant for as long as it is needed, while at the same time ramping up production of the new low-GWP propellant for those customers and regions that are ready to make the switch.
There are a lot of changes happening in the respiratory Pharma industry, what does this mean for Orbia?
We are very excited about these developments, and it’s great to prove that the development of sustainable products also makes real business sense in this industry.
Large pharmaceutical companies have made commitments to their ESG targets and are now partnering with us to help deliver on them. The innovations we have brought to the market are enabling a substantial reduction in both the global warming potential and the carbon footprint of this industry.
We are very pleased about this and the role we have and will continue to play. We are proud of it and believe it represents a great step forward.
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