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

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.