News | December 10, 2024

Bespak And Ozuk Further Strengthen Pressurised Metered Dose Inhaler Product Development Partnership With Low Global Warming Potential Propellant Capability Enhancements

Bespak, a specialist inhalation contract development and manufacturing organisation (CDMO), and OzUK, an independent contract research organisation (CRO) specialising in pressurised Metered Dose Inhaler (pMDI) development, today announced additional capability to strengthen their partnered early-stage product feasibility and development service for customers.

This announcement builds on OzUK’s recent news in which the company unveiled its ATEX-rated pilot plant for low Global Warming Potential (GWP) pMDI product development. The facility is fully compliant with ATEX (Atmosphères Explosibles) directives, meaning OzUK can produce both solution and suspension batches at pilot scale using low GWP propellant HFA-152a that align with larger-scale production, supporting seamless transition to full manufacturing capabilities at customers’ own facilities or at Bespak’s Holmes Chapel site.

In addition to these capabilities, OzUK has an established independent laboratory for initial formulation and component screening, formulation feasibility and product development. Now, through their partnership with Bespak, OzUK can also offer customers access to extended development services: following early-stage development utilising OzUK’s laboratory and pilot-scale processes, products can transfer seamlessly to Bespak’s new HFA-152a GMP filling line for clinical supply at its Holmes Chapel site. This collaboration therefore creates a flexible and efficient pathway for pMDI developers, providing agility and pace without compromising safety or compliance.

Bespak continues to develop its leading position in the transition to low GWP propellants through its partnerships with independent industry specialists such as OzUK, alongside its own extensive in-house capabilities across its Holmes Chapel and King’s Lynn sites in the UK. Meanwhile, OzUK has a strong track record in early-stage pMDI formulation feasibility and development and an expanding Chippenham, UK facility that complements Bespak’s footprint, allowing the two teams to work seamlessly together when required by clients. As a result, following the recently-announced intention to close Bespak’s North Carolina, US, facility earlier this year, the partnership allows a continuation of Bespak’s end-to-end services, from initial feasibility through to commercial supply.

To ensure a seamless service for customers, experts from both companies will work closely together, leveraging OzUK’s expertise and unrivalled track record in pMDI product formulation and development and Bespak’s project management, scale-up and commercialisation capabilities. The teams of researchers are already working together to drive advances in low GWP formulation understanding, and will be presenting results during 2025.

Christ Hirst, CEO of Bespak, said: “We’re thrilled to partner with such a trusted and well-respected team. By drawing on OzUK’s know-how and recently expanded capabilities, this partnership strengthens the development pathway for vital low GWP pMDIs. We’re also excited to bring our end-to-end pMDI services fully into the UK, reflecting the manufacturing excellence we have here, and bringing the entire low GWP pMDI value chain together.”

Robert Johnson, COO of OzUK, said: “By partnering with Bespak, we can help drive the low GWP pMDI transition with agility here in the UK. We’re excited by what’s possible as we continue to deliver our service as an independent research centre, and in parallel, work with the trusted Bespak team to offer the most extensive reformulation service to our customers. This seamless offering from early-stage development to clinical and ultimately commercial supply in partnership with Bespak is a winning formula to support the transition to climate-friendly inhalers.”

Source: Bespak