Dr Richard Johnson
Chief Scientific Officer and Founder, Upperton
A Unique Opportunity For Large Pharma
For large pharmaceutical companies, challenges include both the discovery the next breakthrough molecule whilst maximising the value of existing assets. This is particularly true for complex, large-molecule biologics which continue to command significant market share and investment.
One of the biggest upcoming challenges for medium and large-scale pharmaceutical companies is patent expiry. The industry is facing an impending patent cliff of $300bn before 2030, knocking off a sixth of the industry revenue.
Pharma can mitigate this future risk to biologic assets through reformulating and extending patent life of existing assets. One such technology that is attracting growing interest in extending patent life is spray drying.
While spray drying has long been used across pharmaceutical development, its application to biologics remains highly specialised. This is particularly true of CDMOs that typically focus on small molecule APIs. Indeed, only few of these companies have biologics listed on their licence. Additionally, many do not have the specialist skills and equipment to offer spray drying as a service. Even fewer can offer both.
In previous years, this has not been seen as a bottle neck for biologics manufacturers. Most biologics are formulated as a sterile liquid or freeze dried powder with little or no requirement for spray drying. However, this differs for large pharma organisations seeking new lifecycle management strategies for their biologics. Spray drying offers a compelling opportunity from a formulation and patient-centricity perspective. In addition to through the potential creation of new intellectual property, supporting patent extension strategies.
Spray Drying For Extracting Additional Value from Biologic Assets
As biologics approach the end of their exclusivity period, companies must identify ways to differentiate products and maintain competitive advantage. Traditionally, this has involved developing new delivery devices, alternative dosage forms or updated formulations.
With the emergence of spray drying in the biologics field, there are growing applications where this technology can be utilised. This can be to maintain competitive advantage and extend exclusivity. These include the ability of spray drying to engineer dry powders with optimal aerodynamic properties, enabling their delivery via new routes. There is particular interest in the lung or nose. Alternatively, there is growing interest in producing spray dried powders that can be formulated as ultra high concentration suspensions. The benefit of these is that they can be delivered by the subcutaneous route rather than intravenously.
Some key blockbuster biologics approaching the end of exclusivity include Keytruda (Merk and co), Opdivo (BMS), Darzalex (J&J), Ocrevus (Genentech), and Cosentyx (Novartis). Spray drying could offer another opportunity for big pharma to clearly differentiate their asset. Therefore extending the life of their patent.
These advancements can provide meaningful benefits for patients while potentially generating new intellectual property around the formulation, manufacturing process or delivery approach. Crucially, they also clearly differentiate the biologic from its original formulation. Therefore, offering a key opportunity for differentiation.
Why So Few Organisations Can Support Spray-Dried Biologics
Despite the opportunity, facilities and expertise for moving a biologic into a spray-dried format is in surprisingly short supply.
The pharmaceutical industry’s expertise remains largely rooted in small molecule development. Biologics now represent a significant proportion of drug pipelines. Yet still, relatively few organisations possess the facilities, analytical capabilities and regulatory expertise required to work with these highly complex molecules.
The capability becomes even more limited when spray drying is introduced.
Successfully developing spray-dried biologics requires specialist formulation expertise. It also requires extensive analytical testing capabilities to demonstrate that critical quality attributes are maintained throughout development. Every stage must confirm that the molecule retains its structure, activity, stability and performance following the spray-drying process.
CDMOs that can support biologics development globally are, therefore, in short supply, and even fewer can support spray-dried biologics.
This scarcity often forces pharmaceutical companies to engage multiple partners across formulation development, analytical characterisation and manufacturing, increasing project complexity, timelines and cost.
Why Large Pharma Is Looking Beyond Traditional CDMO Models
Historically, large pharmaceutical companies have partnered with CDMOs primarily for manufacturing scale. However, when it comes to spray-dried biologics, the immediate challenge is not commercial-scale production, it is accessing the specialist expertise needed to make the product viable in the first place.
The industry has yet to establish a widely available large-scale manufacturing model for spray-dried biologics, especially in those applications that require aseptic processing, for example ultra high concentration biologics. Consequently, pharmaceutical companies are increasingly seeking partners that can help de-risk development programmes, generate proof-of-concept data and establish scalable processes for the future.
This is where specialist organisations can offer significant value.
Rather than simply providing manufacturing capacity, the right partner can bring together formulation science, biologics knowledge, analytical expertise and spray-drying capabilities within a single development programme.
Bringing Critical Biologics Expertise Under One Roof
At Upperton, we have developed a unique capability in spray-dried biologics that spans a wide range of molecule types, with a proven track record that includes peptides, therapeutic proteins, monoclonal antibodies, cytokines, oligonucleotides and vaccines.
Crucially, we combine spray-drying expertise with extensive biologics analytical testing capabilities. This allows us to thoroughly characterise and assess biologic products throughout development, generating the data needed to demonstrate product integrity, stability and performance.
The ability to conduct this work within a single organisation addresses one of the biggest challenges facing pharmaceutical companies today: finding the facilities, equipment and expertise required for spray-dried biologics development in one place.
Our experience also extends far beyond the UK. We have successfully partnered with companies across the globe to develop and manufacture spray-dried biologic products, supporting programmes from early feasibility work through to advanced development stages. These collaborations have demonstrated the growing international demand for specialist expertise in this area and reinforced the value of integrated development capabilities.
The Future of Biologic Lifecycle Management
As more biologics approach patent expiry, pharmaceutical companies will continue to explore innovative ways to unlock additional value from established assets.
Spray drying offers an attractive pathway. One that has the potential to improve product performance, enhance patient convenience and create new intellectual property opportunities that support lifecycle extension strategies.
For large pharma, the question is increasingly not whether spray-dried biologics have strategic value, but whether they can find the specialist expertise needed to realise that value.
With access to advanced spray-drying technologies, extensive biologics testing capabilities and proven experience supporting global development programmes, specialist partners will play an increasingly important role in helping pharmaceutical companies transform existing biologics into the next generation of differentiated products.