Bespak, a contract development and manufacturing organization (CDMO) focused on orally inhaled and nasal drug-device combination products, unveiled progress in its commitment to the production of low global warming potential (GWP) pressurized metered dose inhalers (pMDIs) with the arrival of its new high-speed commercial filling equipment on site, and commitment to further capacity expansion with an additional high-speed commercial filling line planned.

These expansions will enable Bespak to provide customers with access to manufacturing capacity for both new low GWP pMDI propellants to meet increasing industry demand as propellant transition plans progress. Reflecting this high demand, capacity for the newly delivered line has already been fully reserved, and Bespak will be opening capacity reservations for the new line in the coming weeks.

Over recent years, pharmaceutical companies have worked to replace the propellants used in their pMDIs. Regulations around the use of environmentally damaging propellants have tightened, with the Kigali amendment to the Montreal Protocol resulting in the need to reduce the production and consumption of hydrofluorocarbons (HFCs). Additionally, a need to improve the sustainability of the pharmaceutical industry has meant that individual companies need to reduce their emissions, as current HFC-based propellant emissions can represent a significant proportion of an individual pharmaceutical company’s carbon footprint.

Low GWP manufacturing capacity is in scarce supply, according to Bespak, so the company says it is investing in its manufacturing capacity to solve this problem and support its customers’ transition towards the use of green propellants in pMDI manufacturing. Leading the market as the first CDMO to manufacture pMDIs with HFO-1234ze—a near-zero GWP propellant—at commercial scale, Bespak has moved quickly to secure its new state-of-the-art filling lines. These lines, from DH Industries (Pamasol), will expand the capacity at its Holmes Chapel site and will be capable of manufacturing with both HFA-152a and HFO-1234ze, the two new climate-friendly propellants. This means that customers have access to both types of currently available green propellants, supporting customers’ transition needs and multiple types of pMDIs for the benefit of patients. While capacity has already been fully reserved for the newly delivered line, the further expansion is progressing to plan and Bespak will be running a process to allocate this capacity to customers in August.

With this expansion Bespak now has the following capabilities:

• Good Laboratory Practice (GLP) capability in North Carolina (US) for both propellants (HFO-1234ze/HFA-152a) for formulation feasibility and product development;
• Clinical-scale Good Manufacturing Practice (GMP) capability in Holmes Chapel (UK) for HFO-1234ze now and HFA-152a by Q3 2024; and
• Commercial-scale GMP capability in Holmes Chapel for HFO-1234ze now and HFA-152a by Q4 2027.

“The change to low GWP is accelerating and this is creating a major gap between demand and the available capacity for low-GWP pMDI filling,” said Simon Gardner, business development director at Bespak. “This acceleration in adoption of sustainable low-GWP propellants will place increasing pressure on global pMDI supply chains that will further increase as customers inevitably make commitments to change to HFA-152a and HFO-1234ze propellants in the coming months. It appears likely that some companies will find it hard to meet their transition timelines as the capacity that is currently available is taken up. At Bespak we recognize this, and our focus is to support the transition of as many pMDI formulations as possible, ensuring essential pMDI products remain available for patients.”

Richard Turner, head of business development at Bespak, said, “Bespak has invested significantly to support the industry in its transition to low GWP, and the demand we are seeing is commensurate with the lack of capacity out there. We have also put in place a network of experts to create a simplified roadmap for the adoption of the new propellants, such as our partnerships with H & T Presspart, Honeywell, MEU and Oz-UK. We are delighted by the response from customers and look forward to working together to transition their products.”