Bespak and Orbia Fluor & Energy Materials Collaborate on Climate-Friendly Inhalers

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Bespak, a contract development and manufacturing organization that specializes in inhalation products, announced on Nov. 6, 2024 that it is partnering with Orbia Advance Corporation, S.A.B. de C.V (BMV: ORBIA) Four & Energy Materials (Orbia Fluor & Energy Materials) to transition to climate-friendly inhalers. As part of the collaboration, Orbia, a supplier of fluoroproducts and technologies, will provide Bespak with its low global warming potential (GWP) propellant, Zephex 152a for use in Bespak’s pressurized metered dose inhalers (pMDIs).

Bespak is making the transition to the GWP propellant as part of the overall pMDI industry’s commitment to sustainable solutions. The company verified the use of producing pMDI formulations with GWP propellants with the assistance of its network of partners and its good laboratory practice (GLP) lab-scale testing, as well as its clinical- and commercial-scale good manufacturing practice (GMP) capabilities. Bespak will also utilize Orbia’s clinical-scale GLP and GMP capabilities.

The two companies will work closely at their locations in North West, England, with support from Bespak’s King’s Lynn, United Kingdom, location, which has conducted research on a range of valves and actuators.

“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 utilizing Zephex 152a,” said Chris Hirst, CEO of Bespak, in a press release (1). “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 commercialization at our Holmes Chapel site.”

“This is another step forward in bringing pMDIs using our low GWP medical propellant Zephex 152a to the market,” said Markus Laubscher, general manager of Orbia Fluor & Energy Materials Pharma Business Unit, in the release. “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.”

Bespak has made recent investments in its development services through its market approval services for all pMDI formulations and propellants. It has also increased capacity for commercial supply. In October 2024, the company announced that, in connection with H&T Presspart, it had added a GMP pilot-scale filling line for pMDIs to produce GWP propellants HFDA-152a and HFO-1234ze (2). The new filling line provide access to small-scale GMP capabilities for development programs and clinical trials.

“This new low GWP pilot-scale filling capability addresses the short-term market need for clinical trial supply and will help pharma companies to advance their low GWP development programs towards commercialization,” Hirst said in the press release. “When added to our rapidly expanding low GWP commercial-scale capability, it is clear that we can now offer customers a complete transition pathway.”

“H&T Presspart is committed to supporting the industry in transitioning to low GWP propellants,” said Christian Krätzig, president of H&T Presspart, in the release. “In our partnership with Bespak, we are now leveraging our combined expertise to create the infrastructure needed for small-scale manufacturing with low GWP propellants. The launch of a GMP pilot-scale filling line is an important step forward, and we are excited about future collaborations that will help to create a more sustainable pMDI platform for the next generation.”

References

1. Bespak. Bespak and Orbia Fluor & Energy Materials Unite to Accelerate Transition to Climate-friendly Inhalers. Press Release. Nov. 5, 2024.
2. Bespak. Bespak & H&T Presspart Announce Availability of GMP Pilot Line for Low GWP pMDIs. Press Release. Oct. 8, 2024.