Improving protein therapeutic development through cloud-based data integration.

ABSTRACT

Pharma 4.0 is a digital evolution of the pharmaceutical industry that automates scientists' traditional workflows with the implementation of modern technologies like cloud pipelines, artificial intelligence, robotic platforms, and augmented reality. Lab data capture (LDC) is an essential strategy for initiating Pharma 4.0 that aggregates and harmonizes siloed lab data from analytical instruments, reporting systems, and operational platforms. This publication describes the execution of LDC within a quantitative PCR (qPCR) workflow using the Tetra Data Platform (TDP). We selected this workflow because the qPCR instrument, the ViiA7, generates discrete file-based data that documents execution of individual assays for quantifying residual DNA throughout biologics process development and product profiling. TDP executes LDC through the deployment of file scanning software agents, scanning and ingestion processes, and a cloud-based parsing pipeline that harmonizes source data. Web applications were developed to query, visualize, and interpret harmonized qPCR data for automated experiment data processing and process control charting from the TDP platform. Our implementation of LDC enables analytical researchers to harness FAIR (Findable, Accessible, Interoperable, Reproducible) data practices across the organization and establishes a "compliance-by-code" culture in development labs.