SinS - Abstract

Abstract Information :

Currently analytical methods used in the pharmaceutical industry face the twin challenges of interoperability and reproducibility due to the methods being stored and managed in paper form. They also are frequently stored in proprietary software platforms. Improving both automation and interoperability of analytical methods may: improve quality, optimize efficiency, and reduce cost by: improving ability to effectively transfer method, enabling digital b2b method transfer (e.g. from CRO to Pharma), and reducing or eliminating the need to manually enter data from paper methods into electronic platforms, enhancing reproducibility, and providing full content of the experimentation, improve out of spec (OOS) analysis capability, and potentially leverage data standards for machine-learning. Improving automation and interoperability of analytical methods may improve quality, enhance efficiency, and reduce cost. Such benefits are expected by enabling digital b2b method transfer (e.g. from CRO to Pharma), reducing manual entry and cost associated with human transcription errors, faster reproducibility, enhancing data use and re-use with thorough contextual meta-data, and improving out of spec (OOS) analysis capability. Looking forward, this infrastructure may help leverage data standard for machine-learning. In essence, easier compliance fosters more science. We have completed three phases of this projects: (1) Transferred methods across Agilent 1260 and 1290 using OpenLab CDS via ZONTAL Space and overlayed HPLC data acquired from MSD and GSK on the ZONTAL Space; (2) Transferred methods across Agilent 1260 and 1290 using both OpenLab and Empower CDS via Zontal Space and Orbis Gateway, overlayed data acquired from Empower and OpenLab CDS on the ZONTAL Space, and submitted sample sets (including the method) from the ZONTAL Space directly onto Empower; (3) Transferred methods across five unique configurations of Agilent 1100-1200s instruments using OpenLab CDS. The next step of the project includes method transfer across different manufacturers’ hardware.