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References from Industry-defined opportunities for advancing big data capabilities in biopharmaceutical manufacturing. Local targets link to admitted publications; unresolved targets remain external evidence.
Conceptualizing the digital thread for smart manufacturing: a systematic literature review
10.1007/s10845-024-02407-1 · 2024 · External reference
Overview of best practices for biopharmaceutical technology transfers
10.5731/pdajpst.2015.01086 · 2015 · External reference
Interoperability levels and challenges of digital twins in cyber–physical systems
10.1016/j.jii.2024.100714 · 2024 · External reference
Industry 4.0 for pharmaceutical manufacturing: preparing for the smart factories of the future
10.1016/j.ijpharm.2021.120554 · 2021 · External reference
Opportunities and challenges for model utilization in the biopharmaceutical industry: current versus future state
10.1016/j.coche.2022.100813 · 2022 · External reference
Overcoming barriers to patient adherence: the case for developing innovative drug delivery systems
10.1038/s41573-023-00670-0 · 2023 · External reference
Exploration and evaluation of modular concepts for the design of full-scale pharmaceutical manufacturing facilities
10.1002/bit.28539 · 2023 · External reference
A resource-based perspective on information technology capability and firm performance: an empirical investigation
10.2307/3250983 · 2000 · External reference
Sysrev: a FAIR platform for data curation and systematic evidence review
10.3389/frai.2021.685298 · 2021 · External reference
10.1007/978-3-319-21569-3
10.1007/978-3-319-21569-3 · 2016 · External reference
Biologics guidances
2025 · External reference
Artificial intelligence and machine learning in software as a medical device
2024 · External reference
Digital twins in pharmaceutical and biopharmaceutical manufacturing: a literature review
10.3390/pr8091088 · 2020 · External reference
Recent advances in integrated process analytical techniques, modeling, and control strategies to enable continuous biomanufacturing of monoclonal antibodies
10.1002/jctb.6765 · 2022 · External reference
Chapter 26 - the biomanufacturing of biotechnology products
10.1016/b978-0-12-404730-3.00026-9 · 2014 · External reference
Review of AlphaFold 3: transformative advances in drug design and therapeutics
10.7759/cureus.63646 · 2024 · External reference
Unresolved reference
2021 · External reference
Challenges and trends in biopharmaceutical facility design
2024 · External reference
10.1007/978-3-031-42592-9_12
10.1007/978-3-031-42592-9_12 · 2023 · External reference
Gaining agility through IT personnel capabilities: the mediating role of IT infrastructure capabilities
10.17705/1jais.00135 · 2007 · External reference
Development, and translation, board on health sciences policy, and institute of medicine (iom)
2013 · External reference
Unresolved reference
External reference
Personalized medicine: motivation, challenges and progress
10.1016/j.fertnstert.2018.05.006 · 2018 · External reference
The resource-based theory of competitive advantage: implications for strategy formulation
10.1016/b978-0-7506-7088-3.50004-8 · 1991 · External reference
Prospering in dynamically-competitive environments: organizational capability as knowledge integration
10.1287/orsc.7.4.375 · 1996 · External reference
Unresolved reference
2019 · External reference
Harvesting the benefits of LEAN in biopharmaceutical manufacturing
2009 · External reference
Cost advantages of single-use technologies
2010 · External reference
Exploring the value of AI technology in optimizing and implementing supply chain data for pharmaceutical companies
2023 · External reference
MELLODDY: Cross-pharma Federated Learning at Unprecedented Scale Unlocks Benefits in QSAR without Compromising Proprietary Information [Supporting Information]
10.1021/acs.jcim.3c00799 · 2024 · External reference
Enabling technologies for personalized and precision medicine
10.1016/j.tibtech.2019.12.021 · 2020 · External reference
A reliable automated sampling system for On-Line and real-time monitoring of CHO cultures
10.3390/pr8060637 · 2020 · External reference
Unresolved reference
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Unresolved reference
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Automation
2021 · External reference
Recent innovations in adaptive trial designs: a review of design opportunities in translational research
10.1017/cts.2023.537 · 2023 · External reference
Therapeutic gene editing is here, can regulations keep up?
10.38105/spr.czm9c2w8ig · 2020 · External reference
Progress in biopharmaceutical development
10.1002/bab.1617 · 2018 · External reference
Accelerating biomanufacturing by modeling of continuous bioprocessing—piloting case study of monoclonal antibody manufacturing
10.3390/pr7080495 · 2019 · External reference
Unresolved reference
External reference
Understanding data, information, knowledge and their inter-relationships
2007 · External reference
Unresolved reference
2010 · External reference
Comprehensive manipulation of glycosylation profiles across development scales
10.1080/19420862.2018.1527665 · 2019 · External reference
AI on drugs: can artificial intelligence accelerate drug development? Evidence from a large-scale examination of bio-pharma firms
10.2139/ssrn.3524985 · 2021 · External reference
Understanding the link between information technology capability and organizational agility: an empirical examination
10.2307/41409967 · 2011 · External reference
Pharmacovigilance: reporting requirements throughout a product’s lifecycle
10.1177/20420986221125006 · 2022 · External reference
Benchmark glycan profile of therapeutic monoclonal antibodies produced by Mammalian cell expression systems
10.1007/s11095-023-03628-4 · 2023 · External reference
Personalized medicine could transform healthcare
10.3892/br.2017.922 · 2017 · External reference
Vaccine innovation model: a technology transfer perspective in pandemic contexts
10.1016/j.vaccine.2022.06.054 · 2022 · External reference
Unresolved reference
1995 · External reference
Big data analytics capabilities: a systematic literature review and research agenda
10.1007/s10257-017-0362-y · 2018 · External reference
Unresolved reference
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Unresolved reference
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Continuous manufacturing of recombinant drugs: comprehensive analysis of cost reduction strategies, regulatory pathways, and global implementation
10.3390/ph18081157 · 2025 · External reference
Advances in bioreactor control for production of biotherapeutic products
10.1002/bit.28346 · 2023 · External reference
Enhancing biopharmaceutical supply chains: strategies for efficient drug formulary development in emerging markets
10.54660/ijmbhr.2022.3.1.73-82 · 2022 · External reference
Unresolved reference
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About model validation in bioprocessing
10.3390/pr9060961 · 2021 · External reference
Bioprocess control: current progress and future perspectives
10.3390/life11060557 · 2021 · External reference
Effect of information systems resources and capabilities on firm performance: a resource-based perspective
10.1080/07421222.2005.11045820 · 2005 · External reference
A new theoretical understanding of big data analytics capabilities in organizations: a thematic analysis
10.1186/s40537-021-00543-6 · 2021 · External reference
Emerging challenges and opportunities in pharmaceutical manufacturing and distribution
10.3390/pr9030457 · 2021 · External reference
Modeling comes of age in biopharma
2019 · External reference
Single-use disposable technologies for biopharmaceutical manufacturing
10.1016/j.tibtech.2012.10.004 · 2013 · External reference
Capacity planning for batch and perfusion bioprocesses across multiple biopharmaceutical facilities
10.1002/btpr.1860 · 2014 · External reference
Integrated product and manufacturing system platforms supporting the design of personalized medicines
10.1016/j.jmsy.2020.06.016 · 2020 · External reference
Decision making and risk management in biopharmaceutical engineering—opportunities in the age of Covid-19 and digitalization
10.1021/acs.iecr.0c02994 · 2020 · External reference
10.1007/978-3-031-46452-2
10.1007/978-3-031-46452-2 · 2024 · External reference
Data science tools and applications on the way to pharma 4.0
10.1016/j.drudis.2019.06.005 · 2019 · External reference
Small labels, big challenges: solutions for advanced therapy labeling
10.18609/cgti.2020.128 · 2020 · External reference
Why 90% of clinical drug development fails and how to improve it?
10.1016/j.apsb.2022.02.002 · 2022 · External reference
Biopharmaceutical manufacturing: historical perspectives and future directions
10.1146/annurev-chembioeng-092220-125832 · 2022 · External reference
IS capabilities, supply chain collaboration and quality performance in services: the moderating effect of environmental dynamism
10.1108/imds-08-2021-0496 · 2022 · External reference
Unresolved reference
2018 · External reference
Unresolved reference
2022 · External reference
Chapter 4 - scale up of biopharmaceuticals production
10.1016/b978-0-12-813629-4.00004-8 · 2018 · External reference
Unresolved reference
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Unresolved reference
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Managing the innovation supply chain to maximize personalized medicine
10.1038/clpt.2013.228 · 2014 · External reference
Harnessing the potential of machine learning for advancing “Quality by Design” in biomanufacturing
10.1080/19420862.2021.2013593 · 2022 · External reference
Unresolved reference
2009 · External reference
Unresolved reference
2024 · External reference
Current state of implementation of in silico tools in the biopharmaceutical industry—Proceedings of the 5th modeling workshop
10.1002/bit.28768 · 2024 · External reference
Prediction of biopharmaceutical facility fit issues using decision tree analysis
2013 · External reference
Pharmacovigilance in cell and gene therapy: evolving challenges in risk management and long-term Follow-Up
10.1007/s40264-025-01596-9 · 2025 · External reference
Machine learning with domain knowledge for predictive quality monitoring in resistance spot welding
10.1007/s10845-021-01892-y · 2022 · External reference