Recent advances in integrated process analytical techniques, modeling, and control strategies to enable continuous biomanufacturing of monoclonal antibodies
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Title
Recent advances in integrated process analytical techniques, modeling, and control strategies to enable continuous biomanufacturing of monoclonal antibodies
Authors
Keywords
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Journal
JOURNAL OF CHEMICAL TECHNOLOGY AND BIOTECHNOLOGY
Volume -, Issue -, Pages -
Publisher
Wiley
Online
2021-04-22
DOI
10.1002/jctb.6765
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- (2021) Matthias Brunner et al. BIOTECHNOLOGY AND BIOENGINEERING
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- An Integrated Approach for Modeling and Identification of Perfusion Bioreactors via Basis Flux Modes
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- (2021) Vikrant Bansode et al. JOURNAL OF CHEMICAL TECHNOLOGY AND BIOTECHNOLOGY
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- (2021) Anurag S Rathore et al. Current Opinion in Chemical Engineering
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- (2021) Florian Lukas Vetter et al. Processes
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- (2021) Hanna Mahal et al. BIOTECHNOLOGY AND BIOENGINEERING
- Multiplexed Microfluidic Cartridge for At-Line Protein Monitoring in Mammalian Cell Culture Processes for Biopharmaceutical Production
- (2021) Inês F. Pinto et al. ACS Sensors
- Process‐wide control and automation of an integrated continuous manufacturing platform for antibodies
- (2020) Fabian Feidl et al. BIOTECHNOLOGY AND BIOENGINEERING
- Analysis of chemometric models applied to Raman spectroscopy for monitoring key metabolites of cell culture
- (2020) Carl Rafferty et al. BIOTECHNOLOGY PROGRESS
- Fast and automated characterization of monoclonal antibody minor variants from cell cultures by combined Protein-A and multi-dimensional LC/MS methodologies
- (2020) Julien Camperi et al. ANALYTICAL CHEMISTRY
- Continuous Fc detection for protein a capture process control
- (2020) Ujwal Patil et al. BIOSENSORS & BIOELECTRONICS
- Modeling the Residence Time Distribution of Integrated Continuous Bioprocesses
- (2020) Jure Sencar et al. Biotechnology Journal
- Model based strategies towards protein A resin lifetime optimization and supervision
- (2020) Fabian Feidl et al. JOURNAL OF CHROMATOGRAPHY A
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- (2020) Jing Guo et al. Biotechnology Journal
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- Towards a Digital Bioprocess Replica: Computational Approaches in Biopharmaceutical Development and Manufacturing
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- (2020) Vijesh Kumar et al. Annual Review of Chemical and Biomolecular Engineering
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- (2019) Dominik Georg Sauer et al. BIOTECHNOLOGY AND BIOENGINEERING
- Development of a novel, high‐throughput screening tool for efficient perfusion‐based cell culture process development
- (2019) Thomas M. Gagliardi et al. BIOTECHNOLOGY PROGRESS
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- (2018) Lindsay Arnold et al. Biotechnology Journal
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- (2018) Jason Walther et al. Biotechnology Journal
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- (2018) Adam C. Fisher et al. TRENDS IN BIOTECHNOLOGY
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- (2018) Anthony Ehkirch et al. ANALYTICAL CHEMISTRY
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- (2018) Daniel Baur et al. BIOTECHNOLOGY AND BIOENGINEERING
- Glucose monitoring and adaptive feeding of mammalian cell culture in the presence of strong autofluorescence by near infrared Raman spectroscopy
- (2018) Thomas E. Matthews et al. BIOTECHNOLOGY PROGRESS
- Cell culture media for recombinant protein expression in Chinese hamster ovary (CHO) cells: History, key components, and optimization strategies
- (2018) Frank V. Ritacco et al. BIOTECHNOLOGY PROGRESS
- At‐line raman spectroscopy and design of experiments for robust monitoring and control of miniature bioreactor cultures
- (2018) Ruth C. Rowland‐Jones et al. BIOTECHNOLOGY PROGRESS
- Multi-column displacement chromatography for separation of charge variants of monoclonal antibodies
- (2018) Ohnmar Khanal et al. JOURNAL OF CHROMATOGRAPHY A
- Optimized PID controller for an industrial biological fermentation process
- (2018) Omar Khan et al. JOURNAL OF PROCESS CONTROL
- Current status and future challenges in continuous biochromatography
- (2018) Sebastian Vogg et al. Current Opinion in Chemical Engineering
- Glycosylation Flux Analysis of Immunoglobulin G in Chinese Hamster Ovary Perfusion Cell Culture
- (2018) Sandro Hutter et al. Processes
- Development and implementation of an advanced model predictive control system into continuous pharmaceutical tablet compaction process
- (2017) Aparajith Bhaskar et al. INTERNATIONAL JOURNAL OF PHARMACEUTICS
- Integrated microreactor for enzymatic reaction automation: An easy step toward the quality control of monoclonal antibodies
- (2017) Yoann Ladner et al. JOURNAL OF CHROMATOGRAPHY A
- Estimation of adsorption isotherm and mass transfer parameters in protein chromatography using artificial neural networks
- (2017) Gang Wang et al. JOURNAL OF CHROMATOGRAPHY A
- Definition and dynamic control of a continuous chromatography process independent of cell culture titer and impurities
- (2017) Rebecca A. Chmielowski et al. JOURNAL OF CHROMATOGRAPHY A
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- (2017) Neil Templeton et al. METABOLIC ENGINEERING
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- (2016) Maria M. Papathanasiou et al. AICHE JOURNAL
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- (2016) Daniel J. Karst et al. BIOCHEMICAL ENGINEERING JOURNAL
- Closed loop control of lactate concentration in mammalian cell culture by Raman spectroscopy leads to improved cell density, viability, and biopharmaceutical protein production
- (2016) Thomas E. Matthews et al. BIOTECHNOLOGY AND BIOENGINEERING
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- (2016) Daniel J. Karst et al. BIOTECHNOLOGY AND BIOENGINEERING
- Real-time monitoring and control of the load phase of a protein A capture step
- (2016) Matthias Rüdt et al. BIOTECHNOLOGY AND BIOENGINEERING
- Model based adaptive control of a continuous capture process for monoclonal antibodies production
- (2016) Fabian Steinebach et al. JOURNAL OF CHROMATOGRAPHY A
- Nonlinear model predictive control of fed-batch fermentations using dynamic flux balance models
- (2016) Liang Chang et al. JOURNAL OF PROCESS CONTROL
- N-Glycosylation Design and Control of Therapeutic Monoclonal Antibodies
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- (2016) Maxime Boulet-Audet et al. Scientific Reports
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- Quick generation of Raman spectroscopy based in-process glucose control to influence biopharmaceutical protein product quality during mammalian cell culture
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- An overview of FDA-approved biologics medicines
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- (2015) Simon Kluters et al. JOURNAL OF SEPARATION SCIENCE
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- (2015) Sau L. Lee et al. Journal of Pharmaceutical Innovation
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- (2015) Daniel Baur et al. Biotechnology Journal
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- (2014) Ravendra Singh et al. COMPUTERS & CHEMICAL ENGINEERING
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- (2014) Ravendra Singh et al. INTERNATIONAL JOURNAL OF PHARMACEUTICS
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- (2014) James Gomes et al. JOURNAL OF CHEMICAL TECHNOLOGY AND BIOTECHNOLOGY
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- (2014) Stephen Craven et al. JOURNAL OF PROCESS CONTROL
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- (2014) Suzanne S Farid et al. mAbs
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- (2013) Rhian K. Grainger et al. BIOTECHNOLOGY AND BIOENGINEERING
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- (2013) Ravendra Singh et al. EUROPEAN JOURNAL OF PHARMACEUTICS AND BIOPHARMACEUTICS
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- (2013) Candy K.S. Ng et al. FOOD AND BIOPRODUCTS PROCESSING
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- (2013) M. Krättli et al. JOURNAL OF CHROMATOGRAPHY A
- Metabolic profiling reveals that time related physiological changes in mammalian cell perfusion cultures are bioreactor scale independent
- (2013) Spyros I. Vernardis et al. METABOLIC ENGINEERING
- Fed-batch and perfusion culture processes: Economic, environmental, and operational feasibility under uncertainty
- (2012) James Pollock et al. BIOTECHNOLOGY AND BIOENGINEERING
- Analysis of host-cell proteins in biotherapeutic proteins by comprehensive online two-dimensional liquid chromatography/mass spectrometry
- (2012) Catalin Doneanu et al. mAbs
- Rapid High-Resolution Characterization of Functionally Important Monoclonal AntibodyN-Glycans by Capillary Electrophoresis
- (2011) Zoltan Szabo et al. ANALYTICAL CHEMISTRY
- At-line NIR spectroscopy as effective PAT monitoring technique in Mab cultivations during process development and manufacturing
- (2011) Christian Hakemeyer et al. TALANTA
- Downstream bioprocessing: recent advances and future promise
- (2011) Steven M Cramer et al. Current Opinion in Chemical Engineering
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- (2010) Nicholas R. Abu-Absi et al. BIOTECHNOLOGY AND BIOENGINEERING
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- (2010) Peter M. O'Callaghan et al. BIOTECHNOLOGY AND BIOENGINEERING
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