Aerogen, a global leader in high-performance aerosol drug delivery, partnered with the MET Technology Gateway at Atlantic Technological University (ATU) to validate a critical, in-house analytical testing method using advanced High-Performance Liquid Chromatography (HPLC) techniques. This focused collaboration provided the necessary ‘gold standard’ baseline data, enabling Aerogen to confidently integrate their validated method across all relevant manufacturing and method development processes, streamlining internal operations.
The Challenge
Aerogen’s scientists routinely rely on an internal ‘filter wash’ method for critical analytical assessment. While efficient, the method lacked validation against an industry-recognised, external analytical gold standard. The company required independent, expert analysis using highly precise techniques, such as HPLC, to verify the accuracy and precision of their existing method before it could be fully embedded as a reliable standard procedure across their operations.
MET Technology Gateway deployed its state-of-the-art analytical chemistry expertise and resources to provide a swift, focused feasibility study. The core service provided was:
- HPLC Analysis: Utilising High-Performance Liquid Chromatography to generate independent, highly accurate data on the filter wash technique’s performance and results.
- Procedural Clarity: The ATU team compiled a comprehensive report detailing the experimental analysis, methodology, and results, ensuring full knowledge transfer and clarity for Aerogen’s internal team.
Transformation and Impact
The partnership with MET significantly transformed Aerogen’s process validation and procedural confidence:
Method Validation and Process Confidence: The HPLC analysis validated the accuracy of Aerogen’s existing filter wash technique, allowing its confident implementation into all main procedures and performed by all scientists.
Gold Standard Baseline: The collaboration established a benchmark ‘gold standard baseline result’ from which Aerogen can now confidently develop and iterate new in-house analytical test methods.
Overcoming Analytical Bottlenecks: Access to MET’s analytical facilities (HPLC) provided an essential capability that is not available onsite, effectively removing a sporadic but critical technological bottleneck.
Enhanced Procedural Upskilling: The clear communication and comprehensive final report from ATU facilitated an immediate and confident upskilling of internal processes, ensuring all relevant methods are implemented based on validated data.
Ciaran O Leime, Senior Scientist, Aerogen, stated, “The work has given us a gold standard baseline result that we can build on from here. Having MET nearby with the facilities we need gives us peace of mind should any testing requirements emerge that we do not have the capability to complete.”
Overcoming Technological Bottlenecks
For Aerogen, the technological bottleneck was the sporadic requirement for a complex analytical technique – HPLC – which is not available in-house.
Enda Hogan, Graduate Scientist at Aerogen, commented, “Our collaboration with MET allowed us to understand the accuracy of how we performed our filter wash technique and the results we obtained. This validated our method and it could be implemented into our main procedures.”
By providing rapid, accessible access to advanced analytical testing, MET not only validated the initial method but also offered peace of mind (an unforeseen but crucial benefit) that external support is available for future testing requirements.
Future Collaboration and Knowledge Transfer
The engagement was highly satisfactory, with both Aerogen contacts noting that all areas of the project were completed to a high standard.
- Knowledge Transfer: The clear communication and collaborative approach led to quick and easy knowledge transfer, allowing Aerogen to implement the validated method confidently.
- Future R&D Approach: The success of this foundational study has influenced Aerogen’s culture of innovation by opening doors to potential future projects. Ciaran O Leime has indicated interest in more HPLC work to act as baseline data as Aerogen develops its own in-house analytical techniques.
Dr. Jamie Meehan, MET Technology Gateway Manager, stated that “This project is a perfect demonstration of how a focused, high-value technical intervention can yield transformative results beyond just the data. By leveraging MET’s specialist analytical capability, Aerogen gained not only validation but the fundamental procedural confidence to accelerate their internal method development. Our ability to act as an accessible, off-site analytical facility ensures that vital MedTech R&D is never slowed down by a lack of in-house infrastructure.”
The partnership with Aerogen highlights the invaluable role of technology gateways in bridging capability gaps, providing companies with the ‘gold standard’ analytical support needed to drive robust and confident process development.