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Big Data PROGRAM

The Big Data (BD) Program consists of five workstreams focused on data, automated control, analytics, data creation and advanced modeling which demonstrate on how advanced uses of data could be transformative for the manufacturing of biopharmaceuticals
Categories
Drug substance
Equipment and Supplies
Process control
Data

Solution

The Big Data (BD) Program is focused on how advanced uses of data could be transformative for the manufacturing of biopharmaceuticals. The program is composed of five focus areas for further development within the NIIMBL BD program: 1) Standardization and Contextualization of Data, 2) Advanced and Integrated Control, 3) Advanced Sensors and Data Analytics, 4) Creation of Rich Datasets, and 5) Advanced Modeling Approaches.   

Individual and collective improvements in these independent but synergistic areas will support implementation of Manufacturing 4.0 principles in biomanufacturing. All these areas will benefit from collaborative developments by the broad industry, academia, and government network which exists within NIIMBL. In addition to developing solutions, the BD program will adopt new approaches evolved from other industries and collaborative efforts to support other NIIMBL-led programs as data is their common currency. The creation and collective adoption of tools to enable advanced uses of data aligned with the needs of biomanufacturers, suppliers, regulators, and patients supports the NIIMBL mission to accelerate biopharmaceutical manufacturing innovation and maintain US competitiveness in this important industry sector. 

Click here for a more detailed overview of the Big Data Program.

Updates, Related Publications, and Deliverables

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Project Lead

NIIMBL

NIIMBL

Participating Organizations

AstraZeneca

AstraZeneca

Boehringer Ingelheim

Boehringer Ingelheim

Bristol-Myers Squibb

Bristol-Myers Squibb

Cytiva

Cytiva

Federal Stakeholder:  National Institute of Standards and Technology

Federal Stakeholder: National Institute of Standards and Technology

Genentech

Genentech

GlaxoSmithKline, LLC

GlaxoSmithKline, LLC

Merck Sharp & Dohme LLC

Merck Sharp & Dohme LLC

MilliporeSigma/EMD Serono

MilliporeSigma/EMD Serono

Pfizer, Inc.

Pfizer, Inc.

Sanofi

Sanofi

Takeda Pharmaceuticals

Takeda Pharmaceuticals

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