Pistoia Alliance Enables Instant, Secure Transfer of Analytical Methods and Results Data Ahead of FDA Guidance

The Pistoia Alliance has announced an industry first for 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).

“Standardized 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 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.

“Reproducibility of results are critical for facilitating regulatory approvals and getting drugs to market and patients sooner. Yet, instrument method instructions and results data management is 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 digitizing 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. The Pistoia Alliance’s pre-competitive framework provides the perfect forum to start that journey, and we call on companies to join the project and commit to making the change.”

The Pistoia Alliance collaborated with the Allotrope Foundation, using the Allotrope Framework technology stack to ensure interoperability, as well as ZONTAL, which provided the virtual cloud where method information is stored according to FAIR principles. GSK, Merck, Orbis Lab Systems (now part of Astrix), and Agilent provided support for the recent development of the project. The Alliance aims to make the Methods Database an integral part of the system infrastructure in every analytical lab. It is now looking for participation from pharmaceutical companies and CROs to make greater industry adoption of digitalized methods a reality. The Alliance will be speaking about the Methods Hub initiative at The Lab of the Future Europe conference, which the Alliance is a proud partner of.