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Energised by a record-breaking Pharmapack Drug Delivery Innovation Index, which measures R&D confidence across major nations, Pharmapack Europe 2024 (Jan 24th – 25th) kicks off the new year for a drug delivery and packaging industry rapidly returning to full strength.
The event serves as a crucial early glimpse into the technologies shaping the future of patient experience, adherence, and delivery. As 5,500 executives from 300 companies converge in Paris this month, all eyes will be on this year’s StartUp Zone, which is dedicated to exploring technologies set to launch within 24 to 36 months.
One of these exciting innovators is Windgap Medical, a startup pioneering several drug delivery and combination product innovations, including proprietary dual-chamber autoinjectors that aim to simplify, automate, and accelerate the administration of complex drug delivery. We sat down with Windgap Medical co-founder Brent Buchine to discuss their innovative approach and its impact on the future of pharma.
What is happening in the market that is driving demand for a dual-chamber device?
Buchine: As drug formulations are getting more complex, pharmaceutical companies, and patients alike, need devices that can deliver these therapies easily, accurately, and effectively. For example, monoclonal antibodies (mAbs) and other biologics often suffer from weak bonding. This creates challenges with thermal stability and shelf-life, making it difficult to develop liquid-stable formulations. Lyophilising the product to improve stability is a common strategy to address this, but it creates undesired complexity when you have to think about the need to rehydrate and administer the drug.
Additionally, long-acting injectables (LAIs) are becoming increasingly popular. Pharma companies are converting oral solid dosage forms of medications into extended-release injections, which allow patients to replace a daily pill with a monthly or quarterly injection. While much more convenient, many LAIs are based on either microparticle or nanoparticle suspensions that must be mixed on demand, often creating highly viscous solutions that are difficult to prepare and administer.In all of the above examples, and frankly, many more, complex drug therapies would benefit from an easy-to-use, dual-chamber device that mixes and administers the therapy in as few steps as possible while still being able to handle the high viscosity and large volume challenges that may also be present.
This is what drives our company as a team and as a business. Our goal is to support the life-changing capabilities of complex formulations—and make them as easy to mix and deliver. And our Large-Volume, Dual-Chamber platform—what we’ve nicknamed the LVDC—aims to do just that.
How will the LVDC aid therapy development – and how can you help with commercialisation?
Buchine: In the past, when a formulation team ends up with a lyophilised drug, or a complex multi-drug injection, this is a cue to keep working until a more desirable formulation can be developed. This can take millions of dollars and years of work in further development. In some cases, a product may be shelved completely which prevents a much-needed therapy from ever making it to market. The number one way we can help with commercialisation is allowing the formulation teams to stop and take what they have to market without the need to continuously re-formulate.
A key benefit of our mixing device design is the automated, in-device mixing control. Mixing is fully managed by the device, which can create a defined endpoint for when mixing is complete. As a result, shaking and swirling can be removed from the Instructions for Use, ensuring high-quality outcomes by managing how much the user can influence (or disrupt or interrupt) the mixing process. It offers the additional benefit of being operable in 3 steps or less.
With a device capable of delivering these complex injectables, we can shorten timelines and make sure the best-in-class formulation gets to market with all the benefits of improved human factors.
Who are the ideal partners for this platform?
Buchine: We currently have one commercial deal with ALK for an emergency autoinjector on our compact, dual-chamber ANDI platform.
Most of our current customers for the LVDC platform are companies working with mAbs and long-acting injectable suspensions. But any team facing a formulation challenge with liquid stability, high viscosity, high volume, or the need to co-administer two drugs that can’t be co-formulated would benefit from our products.
We can provide real value and speed up the time to market by helping them avoid the need to reformulate—simply by removing the limitations of current drug delivery platforms. And almost any pharma partner can benefit from that.
How does the LVDC differ from what’s on the market now?
In all of our device systems, the mixing is actively and intentionally managed in the device. One push of a button automatically rehydrates the dose and readies it for administration. Many dual-chamber devices on the market today require several manual steps—unpacking separate vials and components, assembling the device, etc. Our gas-powered, large-volume, dual-chamber device houses everything you need and automatically mixes the required dose.
Being gas-powered, rather than based on the conventional spring, the gas pressure can be uniquely tuned to allow for controlled mixing and delivery across a broad spectrum of viscosities and volumes. In addition, its design can reduce packaging and waste while capitalising on increased shelf-life—all of which are better for the patient, the provider, and the planet.
Our LVDC platform also utilises standard primary drug containers so if a pharma company has a standard fill-finish process, they don’t have to reinvent the wheel—they would just get a better delivery system around it.
How does a device like this help pharma companies consider new formulations?
Buchine: There have been developments across mAbs and biologics where you may have a liquid stable formulation, but pairing certain medications together could offer additional indications of use. You might have two liquid drugs but can’t put them in the same primary drug container or co-package them due to drug-drug interaction issues—and you need a way to quickly, easily, and simply deliver two drugs sequentially through the same needle. One of the products we’ve developed based on our platform architecture does exactly this.
Complex drug formulations will only get more complex the further they advance, which is why the onus is on innovative drug delivery companies like Windgap to help make the preparation and administration as simple as possible. Our company mission is to pioneer drug-delivery solutions to live life, without limits. This goes for formulations, too—and we encourage pharma companies to integrate our innovative teams early in the process to open up the possibilities every step of the way.
What is ahead for Windgap in 2024?
Buchine: We are actively working with several pharmaceutical companies and exploring relationships with potential partners—especially with the traction of our recent data. Our Feasibility Programs are getting a lot of attention, and for good reason—they give pharmaceutical companies an opportunity to better understand our device capabilities and the benefits we offer for their specific drug. And we’re obviously looking forward to a powerful Pharmapack Europe 2024 event in a couple of weeks, where we can show this device in action.
Meet Brent and the Windgap Medical team at Booth J17 and marvel at all the innovations, thought leadership, and more at the Pharmapack Europe 2024 conference on January 24th and 25th in Paris, France.