Developing and manufacturing biopharmaceuticals involve many standardized experiments and reports. Most reports contain information from the associated protocol, product quality data from a laboratory information management system (LIMS), information from lab documentation, and performance data from different devices. Currently, these data sources are processed with JMP, Excel, and other software, and then assembled in PowerPoint presentations and Word documents.

I demonstrate an automation of this complete process that was developed in-house with JMP. With the help of a journal, the user is guided through an automated workflow. It uses LIMS data and lab documentation to fill in, e.g., the responses of a design of experiment (DoE) series automatically and proposed illustration options once the subject matter expert (SME) has built a model. These illustrations, chromatography traces, and information from the protocol are then assembled into a PowerPoint presentation and a Word report following a preset template structure.

Generating this automated report saves a significant amount of time for the SME, allowing more time to focus on interpreting the results. Furthermore, by keeping the automation in a single software, data integrity is intact and layout and evaluation standards are followed in every report.