Injectable formulations are the fastest growing segment in the pharmaceutical industry. According to Precedence Research, the global injectable drug delivery market reached U.S. $561 billion in 2021 and is expected to surpass $1,224 billion by 2030.1 Within the injectables space, lyophilized and powdered medications are increasingly prevalent. MarketsandMarkets reported in their 2020 global forecast that more than half of injectable drugs will soon require lyophilization2; already, 16% of the top 100 drugs are lyophilized, a number which rises to 35% when looking at the top 100 biologics.3 This shifting landscape is due to a combination of factors:
- The inherent instability of high-value mAbs and biologics as well as long-acting injectables as liquid formulations
- The challenges of cold-chain management, especially as the pharmaceutical industry grapples with improving sustainability and accessibility
- The difficult, lengthy, and risky process of developing a powdered drug used for clinical trials to a re-formulate a shelf-stable liquid prior to commercial launch
Such a shift creates new challenges and opportunities for drug delivery as innovators across the industry work to find novel approaches for subcutaneous (SC) or intramuscular (IM) injection of these complex therapies.
The Status Quo: Complex Solutions to a Complex Challenge
The most common delivery solution for powdered and lyophilized medications continues to be a kit with two vials, multiple needles, and a syringe.4 This approach requires substantial time and training to properly navigate the complex preparation routine and ensure they can safely transfer fluids, handle needles, mix thoroughly, etc. For some products, a dual-chamber bypass cartridge is used to eliminate the multiple components; however, mixing still requires the user to mix via vigorous shaking, tapping or swirling. In all cases, the successful administration and achievement of the desired patient outcome is threatened by the increased potential for user error and lack of patient adherence.
Given the astounding 40-70% of patients in the US who are noncompliant with their drug regimens, any simplification of administration is a win for patients, caregivers, providers and society at large.5 Recognizing this need, along with the demand for improved patient experience and desire for self-administration, Windgap Medical is disrupting the status quo for dual-chamber drug delivery devices with the development of its latest product platform, the LVDC (Large Volume Dual Chamber) device.
Simplify. Automate. Accelerate.
- Desirability: How easy is the device to use? Will patients want to use it?
- Feasibility: How reliably can the device function as expected?
- Viability: Will there be a demand? Will it be reimbursed?
We at Windgap Medical propose three additional principles to increase the probability of program success:
- Simplify: How easily can the final product be manufactured, shipped and stored? How can the administration process be reimagined to reduce the complexity or number of user steps
- Automate: Which steps can be controlled and completed by the device to reduce user effort or error?
- Accelerate: How quickly can a dose be administered? Can we shorten the path to market
The capabilities of Windgap’s LVDC platform showcase one example of how teams might utilize these principles to ensure effective management of competing performance requirements and encourage greater innovation. The LVDC platform is designed for SC and IM applications requiring reconstitution, liquid/liquid mixing or sequential delivery of two liquid drugs. Its novelty stems from the innovative primary drug container (PDC) architecture which features side-by-side nesting of standard single-chamber cartridges; mixing and delivery occur through Windgap’s proprietary needle hub. The nested layout permits use of ISO-compliant cartridges (from 1mL to 5mL) compatible with standard fill/finish processes, while maintaining a compact and easy-to-handle form factor. The improved device size and drug stability achieved with this platform not only enhances portability to better integrate with patients’ daily lives, but also lowers the product’s carbon footprint through elimination of excess materials, reduced transportation weight and elimination of cold chain management.
LVDC autoinjectors are gas-powered to accommodate mixing and delivery of high viscosities (5000+ cP) and large volumes using tunable plunger speeds, making them ideal for unstable mAbs and other biologics as well as long-acting injectables. The gas-powered reciprocated mixing takes place inside the device with a custom, pre-set cycle time. By eliminating the need for users to mix via shaking, swirling or tapping, the LVDC decreases mixing (and overall administration) time, enables a validated mixing endpoint and offers a streamlined user experience to facilitate self-administration.
Device design cannot be an afterthought in combination product development
Through intentional design simplification to improve manufacturability and usability alongside automation of preparatory steps, Windgap accelerates both the commercialization timelines for pharmaceutical companies and administration times for the patients. Incorporating the aforementioned guiding principles throughout the device development process can reduce risk of improper or incomplete dosing, reduce the time and stress associated with administration, and make it easier for patients to integrate necessary meds into their daily lives.
It is critical to bring a device team to the table early in the development of a combination product, at minimum before the formulation is finalized. Windgap has proven that simple, automated and easy-to-use devices are possible even for complex formulations and raised the bar for injecting simplicity across the industry.
To learn more about Windgap’s product platforms and explore opportunities to partner with us, please visit www.windgapmedical.com or reach out directly to [email protected].
1. “Injectable Drug Delivery Market Size to Hit US$ 1,223.6 Bn by 2030”. Research Report. Precedence Research, May 2022.
2. “Freeze-Drying/ Lyophilization Market by Type (Tray, Shell, Manifold), Scale of operation (Industrial, Lab, Pilot), Application (Food, Pharma & Biotech), Accessories (Loading & Unloading, Monitoring, Vacuum Systems, Drying Chambers) – Global Forecast to 2025”. MarketsandMarkets, Oct 2020.
3. “Lyophilized Injectable Drugs Market – Global Industry Analysis, Size, Share, Growth, Trends, and Forecast 2018-2026”. Research and Markets, Feb 2019.
4. “Let’s Mix Things Up! Innovations in Reconstitution Technologies”. Emergo by UL, Jun 13, 2021.
5. Cattell J, Chilukuri S, Knott D, “Beyond the pill: Creating medical value through technology enablement”. Research Report. McKinsey & Company, May 2022.
6. Allen D, “What’s the Latest in Drug-Delivery Devices?”. MD+DI, May 2019.