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Process analytics 4.0: A paradigm shift in rapid analytics for biologics development

https://doi.org/10.1002/btpr.3177
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What this work says

Outgoing claims: the papers this work cites, builds on, or argues with.

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Bioprocessing in the Digital Age: The Role of Process Models
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Process analytical technology (PAT) for biopharmaceutical products: Part I. concepts and applications
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Process analytical technology (PAT) for biopharmaceutical products: Part II. Concepts and applications
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Real time monitoring of multiple parameters in mammalian cell culture bioreactors using an in‐line Raman spectroscopy probe
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Controlling glycation of recombinant antibody in fed‐batch cell cultures
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Integrated continuous production of recombinant therapeutic proteins
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Closed loop control of lactate concentration in mammalian cell culture by Raman spectroscopy leads to improved cell density, viability, and biopharmaceutical protein production
inferredcites →https://doi.org/10.1002/bit.26383openalex-snapshot
Opportunities and challenges of real‐time release testing in biopharmaceutical manufacturing
inferredcites →https://doi.org/10.1002/bit.27236openalex-snapshot
An NIR‐based PAT approach for real‐time control of loading in Protein A chromatography in continuous manufacturing of monoclonal antibodies
inferredcites →https://doi.org/10.1002/bit.27461openalex-snapshot
Technology outlook for real‐time quality attribute and process parameter monitoring in biopharmaceutical development—A review
inferredcites →https://doi.org/10.1002/bit.27531openalex-snapshot
Online/at‐line measurement, analysis and control of product titer and critical product quality attributes (CQAs) during process development
inferredcites →https://doi.org/10.1002/bit.27532openalex-snapshot
Real‐time monitoring of quality attributes by in‐line Fourier transform infrared spectroscopic sensors at ultrafiltration and diafiltration of bioprocess
inferredcites →https://doi.org/10.1002/bit.27873openalex-snapshot
Online monitoring and control of upstream cell culture process using 1D and 2D‐LC with SegFlow interface
inferredcites →https://doi.org/10.1002/bkcs.10338openalex-snapshot
Development of an Automated, High‐throughput Sample Preparation Protocol for Proteomics Analysis
inferredcites →https://doi.org/10.1002/btpr.1590openalex-snapshot
In situ Raman spectroscopy for simultaneous monitoring of multiple process parameters in mammalian cell culture bioreactors
inferredcites →https://doi.org/10.1002/btpr.1948openalex-snapshot
A novel approach to monitor clearance of host cell proteins associated with monoclonal antibodies
inferredcites →https://doi.org/10.1002/btpr.2205openalex-snapshot
Quick generation of R aman spectroscopy based in‐process glucose control to influence biopharmaceutical protein product quality during mammalian cell culture
inferredcites →https://doi.org/10.1002/btpr.2502openalex-snapshot
Enhanced process understanding and multivariate prediction of the relationship between cell culture process and monoclonal antibody quality
inferredcites →https://doi.org/10.1002/btpr.2633openalex-snapshot
Development of generic raman models for a GS‐KO TM CHO platform process
inferredcites →https://doi.org/10.1002/btpr.2945openalex-snapshot
Application of a kNN ‐based similarity method to biopharmaceutical manufacturing
inferredcites →https://doi.org/10.1002/btpr.2947openalex-snapshot
Application of Raman spectroscopy in monoclonal antibody producing continuous systems for downstream process intensification
inferredcites →https://doi.org/10.1002/cpe.4032openalex-snapshot
Introducing distributed dynamic data‐intensive (D3) science: Understanding applications and infrastructure
inferredcites →https://doi.org/10.1002/elps.200700958openalex-snapshot
Applications of CE SDS gel in development of biopharmaceutical antibody‐based products
inferredcites →https://doi.org/10.1002/elps.201000619openalex-snapshot
A high‐throughput microchip‐based glycan screening assay for antibody cell culture samples
inferredcites →https://doi.org/10.1002/elps.201200644openalex-snapshot
Automated sample preparation for CE‐SDS
inferredcites →https://doi.org/10.1002/elps.201300545openalex-snapshot
Absolute quantitation of host cell proteins in recombinant human monoclonal antibodies with an automated CZE ‐ ESI ‐ MS / MS system
inferredcites →https://doi.org/10.1002/jsc.2185openalex-snapshot
Towards digital transformation: Lessons learned from traditional organizations
inferredcites →https://doi.org/10.1007/978-1-0716-0775-6_6openalex-snapshot
Technical Optimization for the High-Throughput Purification of Antibodies on Automated Liquid Handlers
inferredcites →https://doi.org/10.1007/s00216-019-02096-3openalex-snapshot
Multivariate data analysis of capacitance frequency scanning for online monitoring of viable cell concentrations in small-scale bioreactors
inferredcites →https://doi.org/10.1007/s00216-019-02318-8openalex-snapshot
Multi-attribute PAT for UF/DF of Proteins—Monitoring Concentration, particle sizes, and Buffer Exchange
inferredcites →https://doi.org/10.1007/s00449-019-02216-4openalex-snapshot
Monitoring online biomass with a capacitance sensor during scale-up of industrially relevant CHO cell culture fed-batch processes in single-use bioreactors
inferredcites →https://doi.org/10.1007/s007690050324openalex-snapshot
The impact of LIMS design and functionality on laboratory quality achievements
inferredcites →https://doi.org/10.1007/s10295-018-2009-5openalex-snapshot
Biotechnology software in the digital age: are you winning?
inferredcites →https://doi.org/10.1007/s11018-011-9638-7openalex-snapshot
Laboratory information management systems in the work of the analytic laboratory
inferredcites →https://doi.org/10.1016/j.aca.2015.08.050openalex-snapshot
In-line and real-time prediction of recombinant antibody titer by in situ Raman spectroscopy
inferredcites →https://doi.org/10.1016/j.chroma.2016.05.076openalex-snapshot
A robust robotic high-throughput antibody purification platform
inferredcites →https://doi.org/10.1016/j.chroma.2018.03.005openalex-snapshot
In-line Fourier-transform infrared spectroscopy as a versatile process analytical technology for preparative protein chromatography
inferredcites →https://doi.org/10.1016/j.coche.2015.07.005openalex-snapshot
Perspectives on integrated continuous bioprocessing — opportunities and challenges
inferredcites →https://doi.org/10.1016/j.coche.2018.09.002openalex-snapshot
Advances in process control strategies for mammalian fed-batch cultures
inferredcites →https://doi.org/10.1016/j.drudis.2019.06.005openalex-snapshot
Data science tools and applications on the way to Pharma 4.0
inferredcites →https://doi.org/10.1016/j.ijpharm.2019.06.036openalex-snapshot
Cyber-physical-based PAT (CPbPAT) framework for Pharma 4.0
inferredcites →https://doi.org/10.1016/j.jchromb.2018.06.037openalex-snapshot
Achievements in robotic automation of solvent extraction and related approaches for bioanalysis of pharmaceuticals
inferredcites →https://doi.org/10.1016/j.jchromb.2021.122540openalex-snapshot
Automated mass spectrometry multi-attribute method analyses for process development and characterization of mAbs
inferredcites →https://doi.org/10.1016/j.jpba.2012.02.001openalex-snapshot
Development and validation of an alpha fetoprotein immunoassay using Gyros technology
inferredcites →https://doi.org/10.1016/j.jprot.2016.09.011openalex-snapshot
On-column trypsin digestion coupled with LC-MS/MS for quantification of apolipoproteins
inferredcites →https://doi.org/10.1016/j.procbio.2015.03.005openalex-snapshot
At-line mid infrared spectroscopy for monitoring downstream processing unit operations
inferredcites →https://doi.org/10.1016/j.psep.2018.06.031openalex-snapshot
Pharma Industry 4.0: Literature review and research opportunities in sustainable pharmaceutical supply chains
inferredcites →https://doi.org/10.1016/j.tibtech.2009.06.006openalex-snapshot
Roadmap for implementation of quality by design (QbD) for biotechnology products
inferredcites →https://doi.org/10.1016/j.trac.2016.12.011openalex-snapshot
The dawn of unmanned analytical laboratories
inferredcites →https://doi.org/10.1016/s1535-5535(04)00192-3openalex-snapshot
High Throughput Mapping of Protein-Protein Interactions: Automation of the Yeast Two-Hybrid System
inferredcites →https://doi.org/10.1021/ac0027082openalex-snapshot
Product Review: Implementing LIMS: A “how-to” guide.
inferredcites →https://doi.org/10.1021/acs.analchem.6b01956openalex-snapshot
High-Throughput, Automated Protein A Purification Platform with Multiattribute LC–MS Analysis for Advanced Cell Culture Process Monitoring
inferredcites →https://doi.org/10.1021/acs.analchem.7b02228openalex-snapshot
On-Line Ion Exchange Liquid Chromatography as a Process Analytical Technology for Monoclonal Antibody Characterization in Continuous Bioprocessing
inferredcites →https://doi.org/10.1038/d41573-020-00001-7openalex-snapshot
2019 FDA drug approvals
inferredcites →https://doi.org/10.1038/nbt.4305openalex-snapshot
Biopharmaceutical benchmarks 2018
inferredcites →https://doi.org/10.1038/nbt0109-26openalex-snapshot
Quality by design for biopharmaceuticals
inferredcites →https://doi.org/10.1038/s41596-018-0014-9openalex-snapshot
High-throughput and high-sensitivity phosphoproteomics with the EasyPhos platform
inferredcites →https://doi.org/10.1038/s41598-017-10487-8openalex-snapshot
High-throughput analysis of N-glycans using AutoTip via glycoprotein immobilization
inferredcites →https://doi.org/10.1038/s41598-017-13701-9openalex-snapshot
Topological-insulator-based terahertz modulator
inferredcites →https://doi.org/10.1080/19420862.2018.1445450openalex-snapshot
Automated high throughput microscale antibody purification workflows for accelerating antibody discovery
inferredcites →https://doi.org/10.1080/19420862.2018.1505178openalex-snapshot
Multi-angle light scattering as a process analytical technology measuring real-time molecular weight for downstream process control
inferredcites →https://doi.org/10.1080/19420862.2020.1770669openalex-snapshot
Biomanufacturing evolution from conventional to intensified processes for productivity improvement: a case study
inferredcites →https://doi.org/10.1177/2211068211435302openalex-snapshot
Automatic Liquid Handling for Life Science: A Critical Review of the Current State of the Art
inferredcites →https://doi.org/10.1177/2211068212455631openalex-snapshot
The First 110 Years of Laboratory Automation: Technologies, Applications, and the Creative Scientist
inferredcites →https://doi.org/10.1177/2211068215608767openalex-snapshot
Fully Automated Sample Preparation for Ultrafast N-Glycosylation Analysis of Antibody Therapeutics
inferredcites →https://doi.org/10.1177/2211068216680331openalex-snapshot
Potential of Laboratory Execution Systems (LESs) to Simplify the Application of Business Process Management Systems (BPMSs) in Laboratory Automation
inferredcites →https://doi.org/10.1177/2472630318762384openalex-snapshot
Automated Preparation of MS-Sensitive Fluorescently Labeled N-Glycans with a Commercial Pipetting Robot
inferredcites →https://doi.org/10.1177/2472630320922803openalex-snapshot
High-Throughput Analysis of Fluorescently Labeled N-Glycans Derived from Biotherapeutics Using an Automated LC-MS-Based Solution
inferredcites →https://doi.org/10.1201/9781315371726-7openalex-snapshot
Quality by Design in Biopharmaceuticals
inferredcites →https://doi.org/10.1309/lmzl47en6kdodmxjopenalex-snapshot
Workflow Analysis Comparing Manual and Automated Specimen Processing for Mass Spectrometry–Based Vitamin D Testing
inferredcites →https://doi.org/10.15252/msb.20199021openalex-snapshot
R2‐P2 rapid‐robotic phosphoproteomics enables multidimensional cell signaling studies
inferredcites →https://doi.org/10.2144/btn-2020-0074openalex-snapshot
Improving Chinese Hamster Ovary Host Cell Protein ELISA Using Ella ® : an Automated Microfluidic Platform
inferredcites →https://doi.org/10.3389/fbioe.2020.00001openalex-snapshot
Cryopreservation of Human iPS Cell Aggregates in a DMSO-Free Solution—An Optimization and Comparative Study
inferredcites →https://doi.org/10.3389/fbioe.2020.571777openalex-snapshot
Automation in the Life Science Research Laboratory
inferredcites →https://doi.org/10.3390/pr6050053openalex-snapshot
A Systematic Framework for Data Management and Integration in a Continuous Pharmaceutical Manufacturing Processing Line
inferredcites →https://doi.org/10.3390/pr7030166openalex-snapshot
Accelerating Biologics Manufacturing by Upstream Process Modelling
inferredcites →https://doi.org/10.4155/bio.09.86openalex-snapshot
Recent Advances in Microfluidic Detection Systems
inferredcites →https://doi.org/10.4155/pbp.15.26openalex-snapshot
Automation of ELISAs & evaluation of emerging technologies for high-throughput quantitation of protein impurities
inferredcites →https://doi.org/10.4161/mabs.20099openalex-snapshot
A high throughput capillary electrophoresis method to obtain pharmacokinetics and quality attributes of a therapeutic molecule in circulation
inferredcites →https://doi.org/10.4324/9781003500971-15openalex-snapshot
International Council for Harmonization
inferredcites →https://doi.org/10.5478/msl.2013.4.2.25openalex-snapshot
An Automated High Throughput Proteolysis and Desalting Platform for Quantitative Proteomic Analysis

What points at this work

Incoming claims: where this work appears in other papers’ reference lists and arguments.

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Broad Protein Content Determination for Biomanufacturing Real-Time Process Monitoring and Control by Dual-Wavelength Absorbance Photometry
inferred← citeshttps://doi.org/10.1002/ansa.70013openalex-snapshot
Current PAT Landscape in the Downstream Processing of Biopharmaceuticals
inferred← citeshttps://doi.org/10.1007/s00216-023-05023-9openalex-snapshot
Micro simulated moving bed chromatography-mass spectrometry as a continuous on-line process analytical tool
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AI-Integrated LC–MS/MS Bioanalytical Platforms for Matrix-Effect Mitigation: Advances in Real-Time Monitoring, Sample Preparation, and Validation Challenges
inferred← citeshttps://doi.org/10.1016/j.bios.2025.117625openalex-snapshot
PAT-on-a-chip: Miniaturization of analytical assays towards data-driven bioprocess development and optimization
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Advances and opportunities in process analytical technologies for viral vector manufacturing
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Analytical figures of merit of a dual-wavelength absorbance approach for real-time broad protein content monitoring for biomanufacturing
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Development of a novel disposable flowcell for spectroscopic bioprocess monitoring
inferred← citeshttps://doi.org/10.1016/j.sciaf.2025.e02771openalex-snapshot
Towards enterprise-wide pharma 4.0 adoption
inferred← citeshttps://doi.org/10.1016/j.seppur.2024.126579openalex-snapshot
Multi-objective optimization of continuous CHO cell clarification using acoustic wave separation
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Non-invasive real-time monitoring of cell concentration and viability using Doppler ultrasound
inferred← citeshttps://doi.org/10.1016/j.slast.2024.100128openalex-snapshot
Piston-driven automated liquid handlers
inferred← citeshttps://doi.org/10.1016/j.tibtech.2022.10.010openalex-snapshot
Machine learning in bioprocess development: from promise to practice
inferred← citeshttps://doi.org/10.1109/iraset64571.2025.11008027openalex-snapshot
Pharma 4.0 Implementation Challenges and Potential Solutions
inferred← citeshttps://doi.org/10.1186/s13036-026-00685-2openalex-snapshot
Host cell protein impurities in therapeutic proteins: overview of advances in detection, nonconventional removal technologies and immunogenicity assessment
inferred← citeshttps://doi.org/10.3389/fbioe.2022.948905openalex-snapshot
Model-based intensification of CHO cell cultures: One-step strategy from fed-batch to perfusion
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Recent Advances and Future Directions in Downstream Processing of Therapeutic Antibodies
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