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

Proteomic analysis of post-translational modifications

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Advances and New Directions in Crystallization Control

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Single-use disposable technologies for biopharmaceutical manufacturing

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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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Dynamic model of CHO cell metabolism

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Separation of 2-aminobenzamide labeled glycans using hydrophilic interaction chromatography columns packed with 1.7μm sorbent

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Middle-Down Analysis of Monoclonal Antibodies with Electron Transfer Dissociation Orbitrap Fourier Transform Mass Spectrometry

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Sensitive Electrochemical Aptamer Biosensor for Dynamic Cell Surface N-Glycan Evaluation Featuring Multivalent Recognition and Signal Amplification on a Dendrimer–Graphene Electrode Interface

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The top‐down, middle‐down, and bottom‐up mass spectrometry approaches for characterization of histone variants and their post‐translational modifications

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Ultrafiltration membrane performance: Effects of pore blockage/constriction

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Modeling of growth and energy metabolism of Pichia pastoris producing a fusion protein

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Integrated Microfluidic Capillary Electrophoresis-Electrospray Ionization Devices with Online MS Detection for the Separation and Characterization of Intact Monoclonal Antibody Variants

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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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Applications of CE SDS gel in development of biopharmaceutical antibody‐based products

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General hybrid multizonal/CFD approach for bioreactor modeling

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Control Systems Engineering in Continuous Pharmaceutical Manufacturing May 20–21, 2014 Continuous Manufacturing Symposium

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Model‐based design of a plant‐wide control strategy for a continuous pharmaceutical plant

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Lab-on-a-Chip hyphenation with mass spectrometry: strategies for bioanalytical applications

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Application of imaging capillary IEF for characterization and quantitative analysis of recombinant protein charge heterogeneity

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High Resolution CZE-MS Quantitative Characterization of Intact Biopharmaceutical Proteins: Proteoforms of Interferon-β1

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The Application of an Automated Control Strategy for an Integrated Continuous Pharmaceutical Pilot Plant

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A tool for selective inline quantification of co‐eluting proteins in chromatography using spectral analysis and partial least squares regression

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A framework for real‐time glycosylation monitoring (RT‐GM) in mammalian cell culture

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Advances in inline quantification of co‐eluting proteins in chromatography: Process‐data‐based model calibration and application towards real‐life separation issues

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Modeling and robust pooling design of a preparative cation-exchange chromatography step for purification of monoclonal antibody monomer from aggregates

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CFD simulation coupled with population balance equations for aerated stirred bioreactors

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Real‐time product attribute control to manufacture antibodies with defined N‐linked glycan levels

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A label‐free methodology for selective protein quantification by means of absorption measurements

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Elastic net with Monte Carlo sampling for data-based modeling in biopharmaceutical manufacturing facilities

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Bioreactor Process Parameter Screening Utilizing a Plackett-Burman Design for a Model Monoclonal Antibody

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Methods development in multimodal chromatography with mobile phase modifiers using the steric mass action model

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Determination of thermodynamic and kinetic properties of biomolecules by mass spectrometry

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Quantification of protein mixture in chromatographic separation using multi‐wavelength UV spectra

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Progress toward forecasting product quality and quantity of mammalian cell culture processes by performance‐based modeling

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Exploring the linkage between cell culture process parameters and downstream processing utilizing a plackett‐burman design for a model monoclonal antibody

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Opportunities for bioprocess monitoring using FRET biosensors

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Control systems technology in the advanced manufacturing of biologic drugs

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An alternate diafiltration strategy to mitigate protein precipitation for low solubility proteins

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A Dynamic, Mathematical Model for Quantitative Glycoprofiling Using Label-Free Lectin Microarrays

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A versatile platform for rapid biologics activity assessment via microfluidic drug-receptor binding assays

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A nanofluidic device for rapid biologics quality control

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Analytical methods for process and product characterization of recombinant adeno-associated virus-based gene therapies

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

Wasalathanthri, D. P., Rehmann, M. S., Song, Y., Gu, Y., Mi, L., Shao, C., Chemmalil, L., Lee, J., Ghose, S., Borys, M. C., et al. (2020) · Biotechnology and Bioengineering · doi:10.1002/bit.27461 · Cited by 177 · see citing works

Bioprocess Control: Current Progress and Future Perspectives

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Essential biopharmaceutical properties of drugs at the gastrointestinal absorption stage (Review)

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Trends on Analytical Characterization of Polysorbates and Their Degradation Products in Biopharmaceutical Formulations

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Analytical Detection and Characterization of Biopharmaceutical Glycosylation by MS

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Secondary Packages cannot Protect Liquid Biopharmaceutical Formulations from Dropping-Induced Degradation

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Biopharmaceuticals derived from genetically modified plants

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