Accelerate the development and adoption of data-driven innovation and standards to increase the speed and resilience of biopharmaceutical manufacturing.
Data-driven technologies optimize the productivity of biopharmaceutical manufacturing and accelerate the delivery of high-quality medicines to patients.
“Big Data” encompasses advanced uses of data and data-driven technologies that could transform the manufacturing of biopharmaceuticals and better meet the needs of biomanufacturers, suppliers, regulators, and patients. Benefits to and impacts on the industry include:
The work of the program is organized around workstreams—topical focus areas—and cross-cutting key capabilities themes.
Method of organizing and storing data within a computer system in a structures format to enable its future access, retrieval, and use.
A formal semantic model that represents a set of concepts and their relationships within a domain
A formal and logical data model which describes data content, structure, format and relationships for a bounded domain
Data Schema Consultant Project
NIIMBL Sponsored Biopharmaceutical Manufacturing Ontology Development Project
Creation and use of virtual representations of a real-world systems using software and hardware to emulate and evaluate complex systems
Use of computer simulations with contextually appropriate data to develop processes by augmenting or replacing experimentation or studies
Cell Culture Glycosylation Multi-Scale Data Driven Mechanistic Modeling (Phase 2)
Protein A Chromatography Multi-Scale Data Driven/Mechanistic Modeling (Phase 2)
The ability of different information systems, devices, and applications to access, exchange, integrate and cooperatively use data
Systems which enable connectivity over many data sources, applications, and servers for immediate access to data as it is generated
Soft sensors and other flexible monitoring systems that incorporate process knowledge to extrapolate beyond the dataset they were informed on
Convened NIIMBL Big Data Program Re-envision Workshop to develop a roadmap for the future of the Program
Funded projects to advance standardization and contextualization, real-time control of critical quality attributes (CQAs), multivariate sensors and analytics, rich data generation, and bioprocess modeling and simulation
Convened workshops to identify needs and opportunities, define priority workstreams, and plan first 2 years of the program
Technical Activities Committee (TAC) prioritized Big Data as an area of focus; industry leaders and subject matter experts met at 2019 National Meeting to begin to define a program
Agilent
AstraZeneca
Boehringer Ingelheim
Bristol-Myers Squibb
EMD Millipore Corporation
Federal Stakeholder: National Institute of Standards and Technology
Pfizer, Inc.
Sanofi
Access more program information, including:
Learn more about how being a member of NIIMBL can grant you and your company access to NIIMBL-led programs and other collaboration opportunities.
