Technology outlook for real‐time quality attribute and process parameter monitoring in biopharmaceutical development—A review

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Characterization of Therapeutic Antibodies and Related Products

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Immunogenicity of Therapeutic Protein Aggregates

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Assessment of Recent Process Analytical Technology (PAT) Trends: A Multiauthor Review

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Two-Dimensional Liquid Chromatography: A State of the Art Tutorial

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Raman spectroscopy as a process analytical technology for pharmaceutical manufacturing and bioprocessing

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Predicting antibody developability profiles through early stage discovery screening

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Development of a Quantitative Mass Spectrometry Multi‐Attribute Method for Characterization, Quality Control Testing and Disposition of Biologics

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Recent Advances in Chromatography for Pharmaceutical Analysis

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Correction: Corrigendum: Differential root transcriptomics in a polyploid non-model crop: the importance of respiration during osmotic stress

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Data science tools and applications on the way to Pharma 4.0

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A View on the Importance of “Multi-Attribute Method” for Measuring Purity of Biopharmaceuticals and Improving Overall Control Strategy

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Biotechnology, Big Data and Artificial Intelligence

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Cross‐scale predictive modeling of <scp>CHO</scp> cell culture growth and metabolites using <scp>R</scp> aman spectroscopy and multivariate analysis

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Quick generation of R aman spectroscopy based in‐process glucose control to influence biopharmaceutical protein product quality during mammalian cell culture

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Multi‐Attribute Method for Quality Control of Therapeutic Proteins

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Challenges and opportunities in biopharmaceutical manufacturing control

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Opportunities and challenges of real-time release testing in biopharmaceutical manufacturing

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A Critical Review of Recent Trends, and a Future Perspective of Optical Spectroscopy as PAT in Biopharmaceutical Downstream Processing

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A Retrospective Evaluation of the Use of Mass Spectrometry in FDA Biologics License Applications

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Multivariate PAT solutions for biopharmaceutical cultivation: current progress and limitations

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Generic <scp>R</scp> aman‐based calibration models enabling real‐time monitoring of cell culture bioreactors

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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

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Biomanufacturing evolution from conventional to intensified processes for productivity improvement: a case study

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In‐line monitoring of amino acids in mammalian cell cultures using raman spectroscopy and multivariate chemometrics models

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Advances in downstream processing of biologics – Spectroscopy: An emerging process analytical technology

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Characterization of therapeutic antibodies and related products by two-dimensional liquid chromatography coupled with UV absorbance and mass spectrometric detection

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Monitoring mAb cultivations with in‐situ raman spectroscopy: The influence of spectral selectivity on calibration models and industrial use as reliable PAT tool

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Cyber-physical-based PAT (CPbPAT) framework for Pharma 4.0

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A machine‐learning approach to calibrate generic Raman models for real‐time monitoring of cell culture processes

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Subvisible (2–100 μm) particle analysis during biotherapeutic drug product development: Part 2, experience with the application of subvisible particle analysis

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Model-based computer-aided framework for design of process monitoring and analysis systems

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Simultaneous monitoring of oxidation, deamidation, isomerization, and glycosylation of monoclonal antibodies by liquid chromatography-mass spectrometry method with ultrafast tryptic digestion

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Development of generic raman models for a GS‐KO ^TM CHO platform process

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In-line and real-time prediction of recombinant antibody titer by in situ Raman spectroscopy

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Enhanced process understanding and multivariate prediction of the relationship between cell culture process and monoclonal antibody quality

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Quality by Design (QbD)-Based Process Development for Purification of a Biotherapeutic

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The versatility of heart-cutting and comprehensive two-dimensional liquid chromatography in monoclonal antibody clone selection

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A Quadrupole Dalton-based multi-attribute method for product characterization, process development, and quality control of therapeutic proteins

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Advanced process monitoring and feedback control to enhance cell culture process production and robustness

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On-Line Ion Exchange Liquid Chromatography as a Process Analytical Technology for Monoclonal Antibody Characterization in Continuous Bioprocessing

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Selective protein quantification for preparative chromatography using variable pathlength UV/Vis spectroscopy and partial least squares regression

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In-line Fourier-transform infrared spectroscopy as a versatile process analytical technology for preparative protein chromatography

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Automatic real-time calibration, assessment, and maintenance of generic Raman models for online monitoring of cell culture processes

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Advances in industrial biopharmaceutical batch process monitoring: Machine‐learning methods for small data problems

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Multiple heart-cutting two dimensional liquid chromatography mass spectrometry: Towards real time determination of related impurities of bio-pharmaceuticals in salt based separation methods

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Case study: The characterization and implementation of dielectric spectroscopy (biocapacitance) for process control in a commercial GMP CHO manufacturing process

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A bootstrap-aggregated hybrid semi-parametric modeling framework for bioprocess development

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Recent Advances in 2D-LC for Bioanalysis

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In-column ATR-FTIR spectroscopy to monitor affinity chromatography purification of monoclonal antibodies

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Use of HPLC as an Enabler of Process Analytical Technology in Process Chromatography

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Knowledge management in the QbD paradigm: manufacturing of biotech therapeutics

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High-Throughput, Automated Protein A Purification Platform with Multiattribute LC–MS Analysis for Advanced Cell Culture Process Monitoring

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Multi‐Attribute PAT for UF/DF of Proteins—Monitoring Concentration, Particle Sizes, and Buffer Exchange

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Hybrid Approach to State Estimation for Bioprocess Control

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Interest of locally weighted regression to overcome nonlinear effects during in situ NIR monitoring of CHO cell culture parameters and antibody glycosylation

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Workflow to set up substantial target-oriented mechanistic process models in bioprocess engineering

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At-line mid infrared spectroscopy for monitoring downstream processing unit operations

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Process monitoring of virus‐like particle reassembly by diafiltration with UV/Vis spectroscopy and light scattering

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Industrial batch process monitoring with limited data

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Robust factor selection in early cell culture process development for the production of a biosimilar monoclonal antibody

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Characterization of mammalian cell culture raw materials by combining spectroscopy and chemometrics

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Raman spectroscopy as a method to replace off‐line pH during mammalian cell culture processes

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Cell culture media analysis using rapid spectroscopic methods

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Monitoring Glycosylation Profile and Protein Titer in Cell Culture Samples Using ZipChip CE-MS

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Role of raw materials in biopharmaceutical manufacturing: risk analysis and fingerprinting

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A design space exploration for control of Critical Quality Attributes of mAb

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A Systematic Framework for Data Management and Integration in a Continuous Pharmaceutical Manufacturing Processing Line

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The Opportunities of 2D-LC in The Analysis of Monoclonal Antibodies

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Mid‐infrared spectroscopy‐based analysis of mammalian cell culture Parameters

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Label-Free, Direct Measurement of Protein Concentrations in Turbid Solutions with a UV–Visible Integrating Cavity Absorbance Spectrometer

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Multi‐Angle Light Scattering as a Process Analytical Technology Measuring Real‐Time Molecular Weight for Downstream Process Control

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Digitization for reliable and efficient manufacturing

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Product Attribute Forecast: Adaptive Model Selection Using Real-Time Machine Learning

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Glucose Monitoring in Cell Culture with Online Ultrasound-Assisted Near-Infrared Spectroscopy

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Estimation and identification in batch processes with particle filters

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Advances in process control strategies for mammalian fed-batch cultures

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The Preeminence of Multivariate Data Analysis as a Statistical Data Analysis Technique in Pharmaceutical R&D and Manufacturing

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Introducing distributed dynamic data‐intensive (D3) science: Understanding applications and infrastructure

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Application of a kNN ‐based similarity method to biopharmaceutical manufacturing

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Biotechnology software in the digital age: are you winning?

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Nuts and Bolts of Protein Quantification by Online Trypsin Digestion Coupled LC-MS/MS Analysis

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Cell Viability in Real Time

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Data Processing in Multivariate Analysis of Pharmaceutical Processes

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Model Maintenance

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Rapid Bioprocess Culture Characterization: System Designed to Enable Real-Time Monitoring of Microbial Cultures

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The analyst's perspective

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Advancing herbal medicine: enhancing product quality and safety through robust quality control practices

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Digital Twins in Pharmaceutical and Biopharmaceutical Manufacturing: A Literature Review

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Process Analytical Technologies – Advances in bioprocess integration and future perspectives

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The role of Raman spectroscopy in biopharmaceuticals from development to manufacturing

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Modern Sensor Tools and Techniques for Monitoring, Controlling, and Improving Cell Culture Processes

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White paper on high‐throughput process development for integrated continuous biomanufacturing

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Limit of Detection of Raman Spectroscopy Using Polystyrene Particles from 25 to 1000 nm in Aqueous Suspensions

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N-1 Perfusion Platform Development Using a Capacitance Probe for Biomanufacturing

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Protein L—More Than Just an Affinity Ligand

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Investigation of Lithium Acetyl Phosphate Synthesis Using Process Analytical Technology

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A brief review on recent development of multidisciplinary engineering in fermentation of Saccharomyces cerevisiae

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Raman and NIR Spectroscopy‐based Real‐Time Monitoring of the Membrane Filtration Process of a Recombinant Protein for the Diagnosis of SARS‐CoV‐2

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Exploring the Correlation between LC–MS Multi-Attribute Method and Conventional Chromatographic Product Quality Assays through Multivariate Data Analysis

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Monitoring E. coli Cell Integrity by ATR-FTIR Spectroscopy and Chemometrics: Opportunities and Caveats

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A Review on Advancement in Analytical Quality by Design (AQbD)

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AutoML‐Driven Soft Sensors for Real‐Time Monitoring of Amino Acids in Mammalian Perfusion Cultures

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Polyphenol-functionalized biosensors for real-time monitoring of oxidative stress and inflammation

Chen, H., Jia, H., Wang, W., Cai, Q., Sun, J., & Cui, C. (2025) · Industrial Crops and Products · doi:10.1016/j.indcrop.2025.121658 · Cited by 7 · see citing works

Spectrally-selective SPR fiber-optic sensor for simultaneous monitoring of glucose, pH, and temperature in biopharmaceutical processes

Guo, P., Wang, K., Du, H., Zhang, L., Li, J., Huo, L., & Li, S. (2026) · Optics & Laser Technology · doi:10.1016/j.optlastec.2025.114645 · Cited by 7 · see citing works

Scaling strategies for bioink manufacturing in bone and cartilage bioprinting: Challenges, innovations, and future perspectives

Chakraborty, S., Islam, F., Desai, S. S., Bhattarai, N., & Azad, M. A. (2026) · Bioprinting · doi:10.1016/j.bprint.2026.e00489 · Cited by 7 · see citing works

Overview of Current Downstream Processing for Modern Viral Vectors

Cashen, P., & McLaughlin, K. A. (2023) · Springer eBooks · doi:10.1007/978-3-031-28489-2_5 · Cited by 7 · see citing works

Process analytics for the manufacturing of nanomedicines: Challenges and opportunities

Aguiam, N., Moura, L. I. F., Oliveira, M. I. L. L., Florindo, H. F., & Lopes, J. A. (2024) · Elsevier eBooks · doi:10.1016/b978-0-323-91819-0.00007-5 · Cited by 7 · see citing works

Non-Destructive Spectral Systems (NDSS) for modern inspection systems in real-time: challenges and industrial perspectives

Blasco, J., Gorla, G., Munera, S., Vitale, R., & Amigo, J. M. (2025) · TrAC Trends in Analytical Chemistry · doi:10.1016/j.trac.2025.118369 · Cited by 6 · see citing works

Validation of the cell culture monitoring using a Raman spectroscopy calibration model developed with artificially mixed samples and investigation of model learning methods using initial batch data

Hara, R., Kobayashi, W., Yamanaka, H., Murayama, K., Shimoda, S., & Ozaki, Y. (2023) · Analytical and Bioanalytical Chemistry · doi:10.1007/s00216-023-05065-z · Cited by 6 · see citing works

Leveraging Process Analytical Technology for Real-Time Control in Biopharmaceutical Manufacturing

Prasad, A. (2026) · Zenodo (CERN European Organization for Nuclear Research) · doi:10.5281/zenodo.19064147

Towards real-time monitoring of therapeutic protein quality in mammalian cell processes

Pais, D. A. M., Carrondo, M. J. T., Alves, P. M., & Teixeira, A. P. (2014) · Current Opinion in Biotechnology · doi:10.1016/j.copbio.2014.06.019 · Cited by 63 · see citing works

Process analytical technology (PAT) for biopharmaceutical products: Part I. concepts and applications

Read, E. K., Park, J. T., Shah, R. B., Riley, B. S., Brorson, K., & Rathore, A. S. (2009) · Biotechnology and Bioengineering · doi:10.1002/bit.22528 · Cited by 217 · see citing works

Process Analytical Technologies – Advances in bioprocess integration and future perspectives

Gerzon, G., Sheng, Y., & Kirkitadze, M. D. (2021) · Journal of Pharmaceutical and Biomedical Analysis · doi:10.1016/j.jpba.2021.114379 · Cited by 179 · see citing works

Accelerating attribute‐focused process and product development through the development and deployment of autonomous process analytical technology platform system

Wu, C., Chan, B., Sarich, Z., Duan, Y., Chen, J., Song, J., Berke, M., Miranda, L. P., & Goudar, C. T. (2024) · Biotechnology and Bioengineering · doi:10.1002/bit.28649 · Cited by 10 · see citing works