The Pistoia Alliance introduces a pioneering update to its Methods Hub project. This cloud-based collaboration tool now enables instant transfer and overlay of analytical methods and results data, bridging the gap between various instrument hardware and software vendors. GSK has successfully implemented the proof of concept, soon to deploy it globally. This aligns with the FDA’s recent notice, promoting digital submissions in Pharmaceutical Quality and Chemistry and Manufacturing Controls (PQ/CMC). To drive digitalisation and Method Database adoption, the Pistoia Alliance calls for broader participation from the pharmaceutical industry and contract research organisations (CROs).
“Standardised digital methods via the Methods Database will drive efficiencies across GSK’s global open-access non-GMP fleet. It will be possible for our US lab to download method instructions from our Singapore team while they are sleeping and upload results so the Singapore team can view them instantly when they wake up,” comments Dr Azzedine Dabo, Lead Investigator for Method Development and In Silico Modelling at GSK. “These Methods Hub updates lay the foundations for the major transformation of analytical experiments. Plans to roll out support of other analytical methods such as mass spectrometry and nuclear magnetic resonance spectroscopy could cut significant time off the overall drug development process, so we can get treatments to patients sooner.”
Companies frequently share analytical methods internally as well as externally with CROs and third parties. Yet, methods shared via email or paper-based formats mean researchers must re-establish methods and manually enter machine parameters. Furthermore, parameters and terminology vary between instrument brands, software and generations, which may delay projects. The extended functionality of Methods Hub overcomes this challenge by enabling the secure transfer of High-Performance Liquid Chromatography (HPLC) method instructions between instruments of different vendors and generations. A cloud-based adapter will convert uploaded method instructions into a vendor-neutral format and make the data available for download, conversion and execution on a different system. This improved methods exchange will drive greater flexibility, reproducibility, and workflow efficiency and make data FAIR and machine-readable from the point of its creation.
“Reproducibility of results is critical for facilitating regulatory approvals and getting drugs to market and patients sooner. Yet, instrument method instructions and results data management are still one of the biggest problems our members face,” comments Dr Birthe Nielsen, Project Manager for Methods Hub. “The FDA clearly sees the benefits of digitising PQ/CMC data for increasing the efficiency of its submissions process. Now is the time for companies to invest in shifting from paper-based methods to digital before this guidance becomes mandatory.”