Exploring the potential (and pitfalls) in on-body large-volume injectors
In a recent Q&A with Healthcare Packaging, CDP’s Clare Beddoes and Stephen Augustyn discuss the latest trends in on-body large-volume injectors (LVIs) and what they expect to see in 2024.
Here are their key takeaways:
There are a growing number of untapped disease states for on-body LVIs
“In terms of large volume drugs that could be appropriate for delivery via an on-body LVI, conditions such as neurological disorders, oncology, and autoimmune diseases present promising opportunities.”
On-body LVIs present both pros and cons when it comes to sustainability
“Compared to traditional autoinjectors, the pros lie in enabling more patients to receive treatment at home, reducing travel and clinic resource usage. However, on-body LVIs are notably more complex than autoinjectors, involving adhesive patches, sterility barriers, intricate fluid paths, and often electromechanical drive systems.”
The two main hurdles to commercializing on-body LVIs are cost and risk
“Companies are understandably cautious about risk, often preferring to launch conventional devices initially, while avoiding adding risk on top of risk with a new device for a new drug product. Technical complexities, novel primary containers, device costs, and manufacturing for lower production volumes create hurdles.”
Regulatory challenges have seen a significant improvement since 2022
“ISO 11608 Part 6 offers a clearer framework than before, when these devices were verified as infusion pumps, focusing on ‘rate accuracy’ and not ‘dose accuracy’. The regulatory route is much better understood and there are now products on the market, which gives confidence to device manufacturers.”
Device manufacturers are pushing to enhance automation for large and small-batch production
“In terms of assembly and packaging, high-speed automation rarely makes sense below 2m units a year, so below that, semi-automated or manual processes remain, adding to the device cost. However, some committed device manufacturers are pushing to enhance automation using well-considered device design and process monitoring.”
In summary, the industry still favours established options like autoinjectors, with some pharma companies preferring to use two autoinjectors rather than deal with the complexity of an on body delivery system. However, as LVIs become more established, the anxiety around their use will diminish.
Missed our keynote at Pharmapack?
In their keynote session this year, resident experts in Combination Products, Head of Drug Delivery Clare Beddoes, and Deputy Head of Drug Delivery Steve Augustyn, asked: Where are all the on-body delivery devices?
Explaining the need to deliver innovation fast, they covered:
- Barriers to market that on-body devices face and how to overcome them.
- How to navigate relevant drug product pipelines, regulations and standards.
- Future drivers for successful LVI development.
“The huge demand for high-volume biologics that was expected to drive on-body systems hasn’t materialized, or the devices are proving extremely complex and difficult to assemble. [But] as LVIs become more established, the anxiety around their use will diminish.”
– Steve Augustyn