Manufacturing Flexibility Voice-of-Customer Survey

A strategic initiative to explore and define the requirements, challenges, and adoption potential of flexible, modular, and smart manufacturing systems in the industry, enabling rapid reconfiguration and decentralized production of biopharmaceuticals.
Categories
Proteins/ Antibodies

Industry Need

The biopharmaceutical industry faces increasing pressure to:

  • Adapt to rapidly changing product demands, especially with the rise of personalized and small-batch therapies.
  • Reduce time-to-market for new products.
  • Lower capital and operational costs associated with traditional, rigid manufacturing facilities.
  • Improve integration and reconfiguration of manufacturing systems to support diverse product portfolios.
  • Avoid vendor lock-in and promote open, interoperable systems.
  • Develop a skilled workforce capable of operating next-generation manufacturing technologies.



Approach

NIIMBL is exploring flexible and modular manufacturing systems that offer:

  • Efficiency through easy integration and reconfiguration of unit operations.
  • Flexibility with on-demand adjustments to production lines using interoperable components.
  • Speed to market via standardized specifications, data, and plug-and-play integration.
  • Cost reduction through reusable equipment, simplified maintenance, and vendor-agnostic systems.
  • Scalability and adaptability to meet evolving clinical and commercial manufacturing needs.

This solution is being validated through a Voice-of-Customer (VOC) research initiative that gathers insights from key industry stakeholders to assess demand, functionality needs, adoption barriers, and readiness for implementation.

Impacts

Insights gathered will inform the industry on how to move to modular, interoperable, and scalable platforms

Identifying barriers to flexible manufacturing will support and promote industry transformation

Value Statement/Outcomes

By implementing modular, flexible manufacturing systems with adjustable production rates and interchangeable components, organizations can cut integration and validation costs by up to 30%, enabling faster changeovers and speed-to-market for multi-product facilities. This project will identify current needs and adoption hurdles.

Outputs/Deliverables

Interview notes and raw data

Mid-point preview with customer interview matrix and respondent profiles

Final readout presentation with ranking of flexibility pillars and hinderances for adoption

Presentations

Rode, C., Presenter, Flexible Manufacturing Workstream and Voice of Customer Survey, NIIMBL National Meeting, Washington, DC, June 24, 2025.

Additional Project Information (Members Only)

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Project Lead

Janssen Research & Development, LLC

Janssen Research & Development, LLC

Participating Organizations

Cytiva

Cytiva

EMD Millipore Corporation

EMD Millipore Corporation

Eli Lilly and Company

Eli Lilly and Company

Emerson Automation Solutions

Emerson Automation Solutions

Merck Sharp & Dohme LLC

Merck Sharp & Dohme LLC

Sartorius Stedim

Sartorius Stedim