Automation changes take weeks to months, often on critical path for tech transfer.
Standard and software allowing true plug and play of unit op components.
Reduce reconfiguration downtime from months to days (assume 4 wks savings).
By implementing Device Network Protocol (DNP) for standardized, plug-and-play device integration, an organization could reduce reconfiguration downtime by an estimated 4 weeks per change, enabling faster technology transfer, lower validation costs, and increased operational flexibility for future-proof biomanufacturing.
Interchangeability Demonstrations- SMART O2 sensors from different vendors used to connect to same HMI using the DNP / MTP automation platform while in-process (Complete December 7, 2021). Videos/recordings available upon request.
Demonstration 1: March 2021. MTP Connectivity using a smart pump Demonstration 2: June 2021. Interchangeability with 1 smart sensor Demonstration 3: July 2021. Interchangeability with 2 smart sensors Beta Demonstration: December 2021. Demonstrate MTP connectivity and interchangeability between 2 smart sensors
Reconfigurability Demonstrations- added new processing capability (glucose control) during pre-process equipment setup without re-programming the HMI and process orchestration layer (Complete July 11, 2023). Videos/recordings available upon request.
Demonstration 1: June 2022. POL augmented with 1 smart actuator and 1 smart sensor. Demonstration 2: November 2022. Extend existing MTP service to smart actuator. Demonstration 3: July 2023. Adding new MTP service. DNP Workshop. March 27th, 2024 in France.
Randolph, P., Rode, C., Polilli, B., Fejoz, L., Reinbigler, R., Phillips, M., Hart, R., Erickson, J., & Kaneshiro, S. Participant, ICB, Bringing Flexibility to Integrated Continuous Biomanufacturing. Poster presentation, October 12, 2022.
Fejoz, L., Presenter, Plug-n-Play Session, NIIMBL National Meeting, Washington, D.C., July 15, 2021.
Fejoz, L., Reinbigler, R. Presenters. Process Intensification Flexibility Workstream: Software and Data, NIIMBL National Meeting, Washington, DC, June 29, 2023.
Tung, G., Presenter, An Approach to Computer System Validation for NIIMBL DNP, NIIMBL National Meeting, Washington, DC, June 24, 2025.
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Amgen Inc.
Bristol-Myers Squibb
CSL Behring, LLC
Cytiva
EMD Millipore Corporation
Eli Lilly and Company
Emerson Automation Solutions
GlaxoSmithKline, LLC
Janssen Research & Development, LLC
Merck Sharp & Dohme LLC
Pfizer, Inc.
Sanofi
Sartorius Stedim
