An award-winning breakthrough in personalized medicine

Our client, LEON, challenged us to develop an easy-to-use nano encapsulation system that enables back-to-back aseptic manufacturing for personalized medicine with reliable quality. Using a holistic and system-level approach, our multidisciplinary team of designers, UX specialists, software, electronics and mechanical engineers worked closely with LEON to develop a functional prototype.

We prototyped a user-friendly pharmaceutical aseptic processing system, the NANOme®, for small-scale nano encapsulation with shorter batch/product changeover times and lower operational cost in comparison to conventional systems.

3D drawing of a lipid nanoparticle with encapsulated genetic material

Personalized medicine for life-threatening diseases

Personalized medicine for life-threatening diseases is a relatively new treatment method with unmet potential. Conventional pharmaceutical manufacturing regimes are not fit for personalized medicines. Nanoparticle drug delivery vehicles, especially lipid nanoparticles, are significantly contributing to the realization of personalized medicine. They provide a versatile and customizable platform for the targeted delivery of therapeutic agents. The ability to manufacture tailored doses to individual patient characteristics enhances treatment efficacy, reduces adverse effects and promotes more precise and patient-centric healthcare interventions.

Encapsulating Active Pharmaceutical Ingredients (API) into nanocapsules, for example genetic material such as DNA or RNA, is a promising approach for various biomedical applications, including gene therapy and drug delivery. Nano encapsulation offers protection to the genetic material from degradation, facilitates cellular uptake, and enhances therapeutic efficacy.

The future of nano encapsulation

Our client, LEON, had a proprietary platform technology for fast, easy, efficient and highly flexible nano encapsulation. They needed our support to incorporate this into a commercially available product. The objective was to develop a processing device that would achieve the following key functions: the ability to generate fluid flow without using pumps and operate using single-use disposable systems.

In order for the API to be encapsulated into nanoparticles, the solution containing the API and the one containing excipients need to be mixed under controlled conditions.

The starting materials are held in single-use containers, which are pre-mounted on a disposable cassette. The cassette is inserted into a benchtop NANOme® device, where liquid flow is generated by applying pressure to both containers. The starting materials flow into the mixing reactor, forming API encapsulated nanoparticles. All tubing and fluid path components are also pre-mounted on the cassette and are single-use. This cassette concept saves time by removing the need for cleaning and sterilizing the equipment after each batch, reducing processing time significantly, while avoiding batch cross-contamination.

Person pressing a screen on the NANOme device

A holistic and user-centered approach to personalized nanoformulation manufacturing

We worked closely with LEON to put together the industrial design vision for their benchtop system.

The user interface of the instrument needed to be efficient, robust and flexible to allow for potential future developments. The client also wanted to run the instrument through a display.

Our team of user experience designers mapped out the user journey including physical user input, user interactions with the screen and the background process of the instrument. Defining a user workflow in this way was a catalyst for the decisions that were later made with our mechanical and software teams on the physical device, including its function and scope.

Assessing technical feasibility

One of LEON’s key requirements was to create a nanoencapsulation device that would avoid the time-consuming changeover involved in existing systems. To achieve this, we needed to ensure the entire flow path, including LEON’s proprietary mixer, could be integrated into a single‑use consumable set.

The first step in this process involved using computational fluid dynamic (CFD) simulations to assess the feasibility of a single-use version of the mixer, which had previously only been manufactured using stainless steel for repeat use. These simulations demonstrated that the subtle geometry variations, resulting from the change of manufacturing method and material, would not affect the proven performance of the mixer, allowing us to proceed with the development with confidence.

Technology derisking

This feasibility assessment unlocked the pathway to a rapid changeover small batch system. The next major technical hurdle was developing a novel pumpless, non-contacting fluid flow architecture to enable a fully closed, aseptic system with no cleaning requirements.

Through creative ideation and benchtop testing, LEON’s concept of pressurizing single-use bags to drive fluid into the mixer was developed into a robust, simple-to-use, and reliable system. It is optimized for near-instant pressure equilibration, resulting in rapid flow ramp-up and high precision. This is key to reducing waste during process stabilisation and guaranteeing the highest degree of product quality.

GMP compliant systems engineering

With the core technical challenges resolved, we progressed into full product development. A key part of this involved integrating the main fluidics architecture with the various elements of the system, including automation, safety, monitoring, usability, GMP, user interface and industrial design.

Building out from the core components of the system – the mixer and the single use disposable cassette – we were able to develop the various subsystems across a multidisciplinary team in tandem, allowing for a faster, aligned development.

The result of this development process was a system which performs reliably and effectively achieves the technical goals, packaged within a design that provides best in class usability and striking visual appeal.
Kella Kapnisi, Head of Cell and Gene Therapies, Team Consulting

User interface development

The design team quickly developed the wireframes with input from the different disciplines working on the project. This early work helped identify commonalities across the system which helped us make a coherent user interface and reduced software development costs. We then developed a high-fidelity user interface by making design improvements including color, working context, usability and typography.

We kept a user-first approach from the initial stages of the project which influenced the way that the instrument was built and helped us advance the prototype. We turned a complex machine into a simple, harmonious and aesthetically coherent experience.

NANOme® represents a significant advancement in nano encapsulation of medications for personalized medicine and takes us one step closer to our vision of making advanced therapies globally accessible.
LEON Nanodrugs

Outcome

We used our full multidisciplinary skillset to help our client develop a groundbreaking pharmaceutical manufacturing device. This instrument drastically improves the standard for producing sterile personalized nanoformulations, while also removing any risk for cross-contamination of the batches.

NANOme® has since received an iF Design Award for its novel design and potential to impact patient lives.

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