Pistoia Alliance enables instant, secure transfer of analytical methods and results data ahead of FDA guidance

Sept. 12, 2023
Successful proof of concept at GSK employs data transfer via cloud to facilitate secure and efficient collaboration across companies, labs and time zones.

The Pistoia Alliance has announced its Methods Hub project; the cloud-based collaborative tool now enables the instant transfer and overlaying of analytical methods and results data in a single platform and between different instrument hardware and software vendors. 

The proof of concept has been successfully implemented at GSK and will now be deployed to global open-access non-GMP fleet. The Methods Hub update follows the publication of an FDA notice as part of the regulator’s ongoing support for digitizing submissions. In line with the Methods Hub goals, the FDA seeks to standardize the digital exchange of data related to Pharmaceutical Quality and Chemistry & Manufacturing Controls (PQ/CMC). To encourage digitalization and drive adoption of the Method Database, the Pistoia Alliance is calling for broader project participation from the pharma industry, as well as contract research organizations (CROs).

The extended functionality of Methods Hub enables 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 instruction 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, workflow efficiency, and make data FAIR and machine-readable from the point of its creation.

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