This project provides a valuable blueprint for the industry to emulate.
Executive Summary
• Lonza wanted to achieve paperless quality control (QC) laboratories using automated digital systems.
• As part of this ambition, Lonza sought an end-to-end (E2E) automated solution to optimize environmental monitoring (EM) at four of its Cell & Gene Manufacturing sites across North America, Europe, and Asia.
• Lonza successfully integrated the MODA-EM® Module with Rapid Micro Biosystems' Growth Direct® System, combining paperless processes with automated microbial enumeration for pharmaceutical QC.
• To our knowledge, the project was the first industry implementation of an E2E automated incubation and read-out process for EM.
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Impact: As a result of the integration, Lonza achieved:
The Growth Direct System automates QC Micro testing and digitizes results to ensure data integrity. The system can export result reports or securely link to a two-way laboratory information management system (LIMS) to completely eliminate manual data entry and drive productivity.