Key Highlights:
- Bespak and Orbia Advance Corporation announced a collaboration intended to accelerate the transition to climate-friendly inhalers utilising Orbia Fluor & Energy Materials’ low global warming potential propellant known as Zephex 152a.
- The shared aim of the collaboration is to advance understanding and enable success in the reformulation and commercialisation of pMDI products globally.
- Bespak can now provide development services up to market approval for all pMDI formulations and propellants, supported by capacity for commercial supply.
Bespak/Orbia
The Bespak and Orbia Fluor & Energy Materials teams hard at work. L to R: Richard Turner, Bespak; Sheryl Johnson, Orbia Fluor & Energy Materials; Jonathan Carr, Orbia Fluor & Energy Materials.
Bespak, a specialist inhalation contract development and manufacturing organisation (CDMO), and Orbia Advance Corporation, S.A.B. de C.V. Fluor & Energy Materials (Koura), a global specialist in the development, manufacture, and supply of fluoroproducts and technologies, announced a collaboration intended to accelerate the transition to climate-friendly inhalers utilising Orbia Fluor & Energy Materials’ low global warming potential (GWP) propellant known as Zephex 152a.
As a result of its commitment to the pMDI industry’s transition from currently-used propellants to more sustainable solutions, Bespak has verified the feasibility of marketed pMDI formulations with low GWP propellants – an achievement enabled by its range of valves and its network of expert partners, underpinned by its own footprint encompassing GLP lab-scale formulation feasibility, product development and analytical testing, clinical-scale GMP capability and commercial-scale GMP manufacturing.
Following significant investments, Bespak can now provide development services up to market approval for all pMDI formulations and propellants, supported by capacity for commercial supply. Most recently, Bespak announced the availability of its clinical supply services utilising HFA-152a as a result of its partnership with H&T Presspart, and its investment in a new high-speed commercial-scale filling line capable of manufacturing with HFA-152a, both at the company’s Holmes Chapel site.
Combining Orbia Fluor & Energy Materials’ innovation in propellant technology and its own GLP and clinical-scale GMP capability with Bespak’s position in pMDI componentry and services, the shared aim of the collaboration is to advance understanding and enable success in the reformulation and commercialisation of pMDI products globally. The companies will focus their activities in their teams working in close geographical proximity at their sites in the North West of England, well-known historically for its pMDI knowledge base. In addition, the technical support provided by Bespak’s team in King’s Lynn, UK, which has conducted research and development over the past five years to advance a range of valves and actuators to ensure unmatched performance with the new generation of propellants, will result in further speed and agility in the reformulation and development process.
Chris Hirst, CEO of Bespak, commented: “We are committed to leading the transition to low GWP propellants in pMDIs, and in collaboration with Orbia Fluor & Energy Materials, we will enable customers to progress their inhaler portfolios utilising Zephex 152a. Our goal is to convert as many formulations as possible to maintain patient access to pMDIs as global regulation evolves, and we look forward to working with Orbia Fluor & Energy Materials to provide customers with a pathway to commercialisation at our Holmes Chapel site.”
Markus Laubscher, general manager of Orbia Fluor & Energy Materials Pharma Business Unit, said: “This is another step forward in bringing pMDIs using our low GWP medical propellant Zephex 152a to the market. We are excited to extend our industry collaborations to Bespak who bring the needed capabilities to the table, from their expertise in valves and actuators, to their demonstrated commitment to clinical and commercial-scale product manufacturing.”