Next Gen Factory Business & Data Mapping

Collaboratively document standard biopharmaceutical manufacturing data workflows and identify future-state improvements for data creation, transformation and use.
Categories
Drug substance
Data

Industry Need

Data flow and information systems in biopharmaceutical manufacturing are often fragmented and misaligned leading to production inefficiencies and delayed decision making. Without a shared framework, efforts to digitalize and optimize manufacturing remain limited, slowing progress toward more agile and resilient manufacturing.

Approach

The project team will develop a comprehensive taxonomy and hierarchical structure of current biomanufacturing domains and map them using business process model and notation (BPMN) to capture shared processes, data inputs/outputs, responsibilities, and interconnections. In addition, the team will use the BPMN maps across all domains to identify best practices to guide the industry toward incremental optimization and digitalization.

Impacts

The data flow models can be tailored for organization-specific processes providing a clear view of all workflows with data inputs/outputs including any bottlenecks, redundancies, and gaps in current operations.

Aligning with industry best practices for factory data flow enables faster, data-driven decision making, improved communication, and reduces the risk of process failures.

The incremental data flow improvement roadmap facilitates stepwise, scalable optimization.

Value Statement/Outcomes

Using and tailoring the BPMN maps to an organization's processes provides a clear end-to-end view of manufacturing workflows and data flows, enabling better visibility and alignment, reducing inefficiencies, and supports faster, data-driven decision-making. The inclusion of typical, better, and best practices offers a practical roadmap for incremental improvements.

Outputs/Deliverables

Master Production Planning BPMN map (Complete)

New Product Introduction BPMN map (Complete)

Posters

Mehrman, S., Presenter, Maximizing Data Flow in the Next Generation Factory One Byte at a Time, NIIMBL National Meeting, Washington D.C., June 26, 2025.

Presentations

Mehrman, S., Presenter, Business Process & Data Mapping – Maximizing Data Flow in the 2nd Gen Factory One Byte at a Time​, NIIMBL National Meeting, Washington D.C., June 25, 2024

Mehrman, S., Presenter, NIIMBL Process Intensification Program 2nd Generation Factory Data Flow Mapping, NIIMBL National Meeting, Washington D.C. June 25, 2025.

Additional Project Information (Members Only)

Login to the NIIMBL member portal to access additional project information, including presentations, progress updates, reports, and more.

Not yet a member? Learn more about which level of NIIMBL membership is right for you and your organization.

Project Lead

NIIMBL

NIIMBL

Participating Organizations

Amgen Inc.

Amgen Inc.

AstraZeneca

AstraZeneca

Bristol-Myers Squibb

Bristol-Myers Squibb

CSL Behring, LLC

CSL Behring, LLC

Cytiva

Cytiva

EMD Millipore Corporation

EMD Millipore Corporation

Eli Lilly and Company

Eli Lilly and Company

Emerson Automation Solutions

Emerson Automation Solutions

Genentech, Inc.

Genentech, Inc.

GlaxoSmithKline, LLC

GlaxoSmithKline, LLC

IPS-Integrated Project Services, LLC

IPS-Integrated Project Services, LLC

Janssen Research & Development, LLC

Janssen Research & Development, LLC

Merck Sharp & Dohme LLC

Merck Sharp & Dohme LLC

Pfizer, Inc.

Pfizer, Inc.

Sanofi

Sanofi

Sartorius Stedim

Sartorius Stedim

Takeda Pharmaceuticals

Takeda Pharmaceuticals