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Pharmapack Europe 2024 returns early in the New Year to the Paris Expo (January 24/25th), with the drug delivery and packaging industry rapidly regaining strength. Notably, the Pharmapack drug delivery innovation index – a measure of R&D confidence across major nations – reached a new record high earlier this month.
The event is widely viewed as a vital early window into many of tomorrow’s technologies that improve patient experience, adherence, and delivery. In particular, the event is well-known as a collective hub of many innovations in development, with its start-up zone dedicated to exploring the technologies that are currently being launched or will come onto the market in two- or three-years’ time.
Ahead of the event we at EPM HQ caught up with Windgap Medical, a start-up pioneering several drug delivery innovations, including a proprietary two-chamber autoinjector that hopes to solve many of the present formulation challenges.
Q) Background: what is happening in the market, why the need for a dual chamber device – what is the pipeline calling for, and what need does it meet?
In general, we’re seeing a progression of formulations getting more complex. We’re starting to see a higher prevalence of lyophilised products, especially when you think about the biologics market and monoclonal antibodies. Weak bonding is creating challenges of thermostability and shelf-life that make it difficult to develop liquid stable formulations. We are also seeing a lot of trends in long acting injectables, where people are taking oral solid dosage forms of medication and converting them into injections so instead of taking a pill daily, you can get a monthly injection or quarterly injection. And we’re starting to see an upward trend in long-acting injectables, and a lot of those products are based on either microparticle or nanoparticle suspensions that need to be mixed on demand. The challenge if you have a lyophilised component or if you have a suspension is the need for a dual-chamber device that can do the reconstitution and mix the product quickly, while also still trying to stay as close to the paradigm of a two-step auto-injector as possible.
In essence, that is fundamentally what Windgap is doing as a business. We see the complexity that’s happening in the world of formulation development and the desire for a two-step solution that’s very easy to use. Our LVDC [Large Volume Dual Chamber] platform is adaptable to different devices, but at its core is a system that enables two separately stored components that are mixed on use within a dual-chamber system.
Q) What are the benefits of this LVDC, how will it aid therapy development – and how long will it take to commercialise? Who are the ideal partners?
One important benefit is that we have mixing control, and we can therefore create a defined endpoint for when mixing is complete. The device allows for you to manage the outcome of human behaviour, protecting the molecule. One of the main differences between this and other autoinjectors is that, rather than being spring powered, it uses gas, so during the manufacturing process, the pressure is set at the required level, which is what allows it to be so tuneable and controlled for the delivery after the mix. We have multiple products stemming from that core platform capability, and it allows us to serve the market across these different areas. Currently, we have one commercial deal in place today with ALK for our epinephrine autoinjector for the treatment of anaphylactic shock. But, more generally, the ideal partner for the LVDC Platform is a company with biologics or injectables. Ideally, it's best suited for someone who has a formulation challenge with the inability to develop a liquid stable form or co-packaging issues. This is where we can provide real value and help speed up their time to market.
Q) What steps does it help mitigate versus other dual-chamber devices?
In our device systems, we actively manage the mixing in the device. So, if you push a button, it automatically rehydrates the dose in a matter of a few seconds. With a lot of the dual-chamber devices on the market, there are still a lot of manual steps just to put and assemble the device together versus a two-step autoinjector where it automatically mixes for you. Our LVDC platform utilises standard primary drug containers, so if a pharma company has a standard fill-finish process, they don’t have to worry about figuring out how they’re going to make that work.
Q) How is a device like this helping pharma companies consider new formulations?
There have been developments across MABs and biologics where you may have a liquid stable formulation, but now we're starting to see companies pair medications together to go after other indications of use. For example, you might have two liquid drugs, but can’t put them in the same primary drug container, and you can’t just mix them and co-package them, so now we're starting to see things where you need to have a device that can deliver one liquid drug and then another liquid drug sequentially, in two steps.
Q) What is ahead for Windgap in 2024?
We are currently working with several pharmaceutical companies, and we have a lot of activity around potential partners for next year. What we do with a lot of our customers is what we call “feasibility programs,” which are small projects to give the pharma company exposure to what our device capabilities are. We are seeing a lot of interest in our LVDC product, and we're starting to march closer towards full development programs where we're going to start commercialising our device for pharmaceutical customers."