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Building a Digitalized End-To-End Process for Environmental Monitoring - a Lonza publication

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:

  • More accurate testing: Lonza reduced human error and improved data integrity.
  • Faster processes: the E2E solution reduced time-to-detection and TTR to 72 hours (down from up to 8 days previously).
  • Better compliance: Increased automation and standardization resulted in greater synergy across data management, aiding compliance and facilitating cost savings.

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.