Louise Righton, Head of Strategic Marketing
Part of something bigger: protecting people and planet through industry collaboration
Balancing needs in a changing landscape
Pressurised metered dose inhalers (pMDIs) are life-saving devices for millions of patients around the world with conditions like asthma or chronic obstructive pulmonary disease (COPD). At Bespak, we have been involved in the production of pMDIs for decades, helping to provide patients with effective, easy-to-use delivery systems. As our industry – like many others – is evolving to be more planet-friendly, we are passionate about ensuring that patients have continued access to tried and trusted medicines. Phasing out currently used propellants, which are powerful greenhouse gases, and incorporating new, greener alternatives is the industry’s current focus. A smooth transition to these low global warming potential (GWP) propellants is therefore hugely important in maintaining the supply of pMDIs to the patients who rely on them, whilst reducing their impact on the environment.
A consortium for global change
Bringing together key players across the industry will be vital for balancing the needs of patients with the needs of the environment. The International Pharmaceutical Aerosol Consortium (IPAC) is a coalition set up to help achieve this. IPAC consists of leading pharmaceutical companies and CDMOs that develop and manufacture pMDIs. It was formed in 1989 in response to the mandate of the Montreal Protocol, designed to combat substances that deplete the ozone layer and address the contribution of inhalation products to climate change.
IPAC initially aimed to support the industry’s transition from ozone-depleting chlorofluorocarbon (CFC) propellants to non-ozone-depleting hydrofluoroalkane (HFA) propellants. It is now focused on our industry’s current transition – from high global warming potential (GWP) HFA propellants to low GWP alternatives, ensuring that global environmental policies relating to inhaled therapies are patient-centric and appropriately balance patient care and sustainability efforts and objectives. By facilitating collaboration and knowledge sharing between the key industry players, IPAC provides a unified voice to engage with regional, national and global environmental policy-makers and help shape the future of our industry.
At Bespak, we were delighted to join IPAC during 2024. We look forward to working with our colleagues in all member companies to drive a smooth global transition to the new generation of propellants.
A leading voice in the transition
As an organisation, we feel that we have a responsibility to support the transition to low GWP propellants by developing the expertise, technologies, processes and capabilities necessary for industry-wide adoption. Our IPAC membership reflects our leading role and all that we have to contribute, built on our significant legacy in the inhaled drug development space. Bespak is represented on the IPAC Board by myself, along with Simon Gardner, Bespak’s Business Development Director focused on low carbon pMDIs. Together, we will help drive the conversation and forge further collaborations across the industry to protect patient access to life-saving medication as we phase out high GWP propellants.
In addition to our membership of IPAC, we have also been a member of its sister organisation, the International Pharmaceutical Aerosol Consortium on Regulation & Science (IPAC-RS), for several years. IPAC-RS is an international association dedicated to advancing the regulatory science of orally inhaled and nasal drug products (OINDPs). It focuses on contributing to effective regulations and standards by sharing the results of its research through conferences, technical journals, webinars and discussions with regulatory bodies. IPAC-RS plays a vital role in ensuring that the right pathways exist to enable product approvals – a fundamental aspect of bringing new, low carbon pMDIs to market. We are proud to be represented by Dr Lei Mao, Director of Inhalation Sciences and Product Development at Bespak, as Vice Chair of the IPAC-RS board, along with Ross Errington, our Head of Drug Product Development.
Leveraging our membership of both organisations, and Board positions in each, we can deepen our engagement with the inhalation community to help shape the implementation of environmental regulations and standards for OINDPs. We are now even more strongly positioned to collaborate with customers, partners and other key stakeholders on industry-wide change.
Delivering on all stakeholder needs
We know that to balance the needs of patient and planet, there are many varied interests to factor in. As a leader in the green propellant transition, we must work with multiple stakeholders to ensure that all aspects of the transition are carefully considered. This necessitates ongoing conversations with patient advocacy groups, prescribing physicians, regulatory agencies, and local and central governments to gather different perspectives. Only then can we make informed recommendations that ensure patients’ needs are met and that we are protecting the planet by driving sustainability as effectively as possible.
In addition to these conversations to drive best practice in transitioning to sustainable solutions, we must also consider the practical requirements of such a significant industry shift and plan for our customers’ changing needs. With regulations in place to phase down high GWP propellants, demand for short-term clinical and long-term commercial manufacturing with low GWP alternatives is growing. In anticipation, we have recently expanded our low carbon pMDI manufacturing capabilities and are in the process of allocating new capacity to customers, ready for the first commercial batches in 2027.
Collaborating for a greener future
In order to assist in the transition of as many pMDI products as possible, Bespak has verified the feasibility of key marketed pMDI formulations with both new low GWP propellant candidates, HFA-152a and HFO-1234ze. This achievement has been enabled by our market-leading range of valves optimised for performance with the new generation of propellants and our network of expert partners, underpinned by our own capabilities. Our footprint encompasses GLP lab-scale formulation feasibility, product development and analytical testing, clinical-scale GMP production capability, and commercial-scale GMP manufacturing.
We are proud to be championing the green transition, to be participating in global industry consortiums, and to be able to affirm our commitment to expanding our offering. Coupled with our longstanding expertise, we are confident we can help maintain a healthy pMDI industry – both here in the UK and at a global scale – so that we can continue working with our customers and partners to provide life-saving therapeutic products to patients now, and long into the future.
