Establishing an Analytical Gold Standard for Process Validation
Global leader in high-performance aerosol drug delivery
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.
Validation of a critical in-house analytical testing method
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.
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Irish Company
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Global Leader
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Feasibility study
“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 completee“.
Ciaran O Leime, Senior Scientist, Aerogen
Aerogen & MET Technology Gateway partnership
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.
The clear communication and collaborative approach led to quick and easy knowledge transfer, allowing Aerogen to implement the validated method confidently.