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Case study: Aerogen

The complex process involved in developing treatments for newborn babies. Interview with Russell Greaney, core development manager, Aerogen.

About your organisation

Aerogen is the world leader in acute care aerosol drug delivery and is synonymous with the effective treatment of respiratory illness among patient groups of all ages, playing a critical role in emergency departments and intensive care units in more than 75 countries worldwide. We are a global company with over 300 active and pending patents, headquartered in Galway, Ireland, with offices in seven other countries and over 350 employees.

What are the physics-based technologies that you are developing in your business?

Aerogen has an extensive knowledge around technologies that specialise in droplet formation. One area of current technological development is in aerosol droplet size. Our motivation is to keep creating industry-leading products that deliver improved patient outcomes. We are currently working on the development of a new breath-synchronised device for delivery of medication to patients. The proposed Aerogen nasal drug delivery platform is a high-efficiency, high-consistency product for delivery of surfactant to pre-term babies.

Current clinical practice for surfactant drug delivery to the infant lung requires invasive intubation which is associated with significant clinical side effects including airway occlusions and brain bleeds.

The aim of this project is to enhance knowledge and capability to develop a product to deliver clinically useful surfactant therapy reliably, reproducibly, and safely to newborns (with the potential for use with other drug types).

Aerogen’s state-of-the-art technology is uniquely positioned to provide clinical solutions for this patient group as it does not add pressure to the circuit due to its low droplet size and low aerosol velocity in comparison to alternative technologies. Aerogen is aiming to release the world’s first nebuliser approved for neonatal aerosol delivery.

What was your innovation journey like?

So, how did we get there? Focusing mainly on the device, Aerogen was technologically uncertain how to nebulise surfactant with a volumetric median diameter (VMD) under three microns with surfactant. This technological uncertainty existed because the aperture diameter and profile in the mesh must be controlled to a greater accuracy and consistency than previously required for other devices.

Designing this type of product comes at a cost, and this project was no different. A major internal capital investment was provided along with some government grants that helped create innovation collaborations with local universities. State-of-the-art equipment (if not available in-house) was purchased, including a full scanning electron microscope with energy-dispersive x-ray spectroscopy, which was required to inspect, measure, and analyse prototypes during the development phase of the project. The device cost increased through each phase, but significant costs were approved at the early concept stage to ensure a good design for manufacture.

“The ability to transfer a concept from the bench to a human clinical trial, treating pre-term infants, shows how physics does have a practical relevance to solving real-life problems.”

–Russell Greaney, core development manager, Aerogen

What is your approach to achieving physics-based innovation?

While the goal sounds simple, the solution was not. We were required to achieve a low VMD (under three microns) with surfactant. A lot of physics went into developing the process and design that allows us to create such low VMD droplets. The nebuliser mesh contains thousands of small holes and is one of the most critical components in the overall system.

The size of these holes helps determine the droplet size, and each hole must be controlled to a high accuracy. The challenge we faced was how to measure each of these micron-sized holes. The process would be time consuming and impractical. Clearly another method was required.

By understanding the relationship between optical density (the measure of light transmittance through a sample) and hole size, and hole size and VMD, we were able to generate an equation with a high level of confidence that linked optical density with VMD. This innovative method allowed us to create an in-process inspection taking only seconds to complete.

How have you gained the skills and knowledge to drive out innovation?

Aerogen in its infancy saw the necessity for research and innovation. Among our many labs is a development lab where metrology and resonance physics is utilised at the highest level. The development lab is quickly becoming an innovation centre where pioneering methods of measurement and analysis are used to help resolve scientific or technological uncertainty.

Training and innovation partnerships are provided when required and continued improvement is ever-present at Aerogen.

“Government grants or rewards that focus on how physics helped achieve an organisation’s objective would help bring the spotlight back to the field of physics.”

–Russell Greaney, core development manager, Aerogen

What has the result of your journey been?

One major result is the success of our first clinical trial, which allowed us to progress to the second trial. Newborn babies represent the most difficult to treat patient group via aerosol therapy. This difficulty is due to their narrow airways and rapid, shallow breathing patterns in conjunction with the narrow breathing circuits used to treat this patient population.

These factors form the principal technological challenges of newborn aerosol delivery, resulting in low aerosol delivery efficiency with associated poor clinical outcomes. To achieve a successful first clinical trial and [to be] currently into our second is a great achievement. There were and are challenges.

Unfortunately, COVID-19 must get a mention here. Clinical trials during normal times are difficult but with COVID-19, the task of getting hospitals to sign up became a major challenge and will ultimately delay the road to commercialisation.

What tips would you give to businesses developing commercial services underpinned by physics and requiring innovation?

There were some key learnings throughout this project. One such positive learning was the communication between functions. While my department’s work was focused on the device (which was one part of a complex system), our team never felt separated from the overall project.

The project manager ensured constant interaction between all functions and regular updates were provided without feeling overpowering. Our department worked on a very technical aspect of the device.

There are a lot of physics-based elements which require complex thinking yet clear delivery. The delivery can be a challenge but with good training and presentation skills this becomes easier, and the message can be delivered to the wider group, which can become vital when you work with multiple functions outside of the physics world.

  • These case studies were commissioned by the IOP from CBI Economics