4.7 Article

A novel framework of surrogate-based feasibility analysis for establishing design space of twin-column continuous chromatography

Related references

Note: Only part of the references are listed.
Article Biotechnology & Applied Microbiology

Pilot-scale demonstration of an end-to-end integrated and continuous biomanufacturing process

Michael J. Coolbaugh et al.

Summary: There is a growing trend in the biopharmaceutical industry towards integrated and continuous bioprocessing, with a successful pilot-scale demonstration showing the feasibility of this approach. The transition from batch to continuous processes offers significant advantages and could improve patient access to biologics drugs.

BIOTECHNOLOGY AND BIOENGINEERING (2021)

Article Biotechnology & Applied Microbiology

Process development and optimization of continuous capture with three-column periodic counter-current chromatography

Ce Shi et al.

Summary: Continuous capture with affinity chromatography is crucial for monoclonal antibody manufacturing. Three different approaches were studied for process optimization, with the model-based approach found to be superior. Optimal residence time for maximum productivity was identified at the boundary of two productivity phases. Comprehensive effects of operating parameters were evaluated, resulting in the prediction of an operation space. Achieving high productivity and capacity utilization was demonstrated using model-assisted tools in continuous capture.

BIOTECHNOLOGY AND BIOENGINEERING (2021)

Article Biotechnology & Applied Microbiology

End-to-end collaboration to transform biopharmaceutical development and manufacturing

John Erickson et al.

Summary: The ambitious 10-year collaborative program aims to invent, design, demonstrate, and support integrated biopharmaceutical manufacturing technology to transform the industry, with goals including improved control, robustness, and security of supply, reduced capital and operating costs, flexibility in product supply, and faster development and supply chain velocity.

BIOTECHNOLOGY AND BIOENGINEERING (2021)

Article Biochemical Research Methods

Optimal loading flow rate trajectory in monoclonal antibody capture chromatography

Joaquin Gomis-Fons et al.

Summary: This study determined the optimal flow rate trajectory during the loading phase of a mAb capture column, showcasing significant improvements in productivity and resin utilization compared to a constant-flow process. The experiments validated the effectiveness of the new approach, while also confirming the importance of model calibration in simulating and optimizing flow trajectories. Additionally, the study demonstrated the scalability of the proposed trajectories across different process scales for the specific resin.

JOURNAL OF CHROMATOGRAPHY A (2021)

Article Biochemical Research Methods

Model-assisted approaches for continuous chromatography: Current situation and challenges

Dong-Qiang Lin et al.

Summary: Continuous bioprocessing, especially in the form of multi-column continuous chromatography, offers numerous advantages such as high productivity, high resin capacity utilization, and reduced waste. Model-assisted approaches are crucial in optimizing and controlling continuous chromatography processes, allowing for efficient evaluation of operating parameters and identification of optimal points. Further development and application of these model-assisted approaches are essential in supporting the advancement of continuous manufacturing in biopharmaceutical production.

JOURNAL OF CHROMATOGRAPHY A (2021)

Article Engineering, Chemical

mAb Production Modeling and Design Space Evaluation Including Glycosylation Process

Ou Yang et al.

Summary: This study utilized mechanistic and dynamic kriging models to enhance monoclonal antibody production efficiency and product quality, successfully identifying the operational design space.

PROCESSES (2021)

Article Biochemical Research Methods

Hybrid Models for the simulation and prediction of chromatographic processes for protein capture

Harini Narayanan et al.

Summary: This study proposes a hybrid modeling approach that combines neural networks and mechanistic models to learn chromatographic unit behavior and fit experimental breakthrough curves, reducing the number of experiments and improving model accuracy.

JOURNAL OF CHROMATOGRAPHY A (2021)

Review Medicine, Research & Experimental

Developments and opportunities in continuous biopharmaceutical manufacturing

Ohnmar Khanal et al.

Summary: The development and implementation of continuous biomanufacturing can reduce production costs, accelerate production speed, and improve drug quality to meet growing market demand. However, challenges remain in the integration, monitoring, and control of traditionally segmented unit operations.
Review Pharmacology & Pharmacy

Economic Analysis of Batch and Continuous Biopharmaceutical Antibody Production: a Review

Ou Yang et al.

JOURNAL OF PHARMACEUTICAL INNOVATION (2020)

Article Computer Science, Interdisciplinary Applications

A sequential constraints updating approach for Kriging surrogate model-assisted engineering optimization design problem

Jiachang Qian et al.

ENGINEERING WITH COMPUTERS (2020)

Article Biochemical Research Methods

Optimization study on periodic counter-current chromatography integrated in a monoclonal antibody downstream process

Joaquin Gomis-Fons et al.

JOURNAL OF CHROMATOGRAPHY A (2020)

Review Chemistry, Applied

Mechanistic Modeling of Preparative Column Chromatography for Biotherapeutics

Vijesh Kumar et al.

ANNUAL REVIEW OF CHEMICAL AND BIOMOLECULAR ENGINEERING, VOL 11 (2020)

Article Engineering, Chemical

Antibody capture with twin-column continuous chromatography: Effects of residence time, protein concentration and resin

Zong-Ye Gao et al.

SEPARATION AND PURIFICATION TECHNOLOGY (2020)

Article Engineering, Chemical

Comparison between Batch and Continuous Monoclonal Antibody Production and Economic Analysis

Ou Yang et al.

INDUSTRIAL & ENGINEERING CHEMISTRY RESEARCH (2019)

Review Computer Science, Interdisciplinary Applications

Advances in surrogate based modeling, feasibility analysis, and optimization: A review

Atharv Bhosekar et al.

COMPUTERS & CHEMICAL ENGINEERING (2018)

Article Operations Research & Management Science

Surrogate-based feasibility analysis for black-box stochastic simulations with heteroscedastic noise

Zilong Wang et al.

JOURNAL OF GLOBAL OPTIMIZATION (2018)

Review Biotechnology & Applied Microbiology

Progression of continuous downstream processing of monoclonal antibodies: Current trends and challenges

Balaji Somasundaram et al.

BIOTECHNOLOGY AND BIOENGINEERING (2018)

Article Engineering, Chemical

Equilibrium Theory Based Design Space for the Multicolumn Countercurrent Solvent Gradient Purification Process

Fabian Steinebach et al.

INDUSTRIAL & ENGINEERING CHEMISTRY RESEARCH (2017)

Article Computer Science, Interdisciplinary Applications

Process analysis and optimization of continuous pharmaceutical manufacturing using flowsheet models

Zilong Wang et al.

COMPUTERS & CHEMICAL ENGINEERING (2017)

Article Chemistry, Physical

Protein adsorption equilibrium and kinetics in multimodal cation exchange resins

Mimi Zhu et al.

ADSORPTION-JOURNAL OF THE INTERNATIONAL ADSORPTION SOCIETY (2016)

Review Biotechnology & Applied Microbiology

Continuous downstream processing for high value biological products: A Review

Andrew L. Zydney

BIOTECHNOLOGY AND BIOENGINEERING (2016)

Article Biotechnology & Applied Microbiology

Identifying a robust design space for glycosylation during monoclonal antibody production

Melissa M. St Amand et al.

BIOTECHNOLOGY PROGRESS (2016)

Article Biotechnology & Applied Microbiology

Performance optimization of continuous countercurrent tangential chromatography for antibody capture

Amit K. Dutta et al.

BIOTECHNOLOGY PROGRESS (2016)

Article Biotechnology & Applied Microbiology

The Future of Industrial Bioprocessing: Batch or Continuous?

Matthew S. Croughan et al.

BIOTECHNOLOGY AND BIOENGINEERING (2015)

Article Engineering, Chemical

Feasibility and flexibility analysis of black-box processes part 2: Surrogate-based flexibility analysis

Amanda Rogers et al.

CHEMICAL ENGINEERING SCIENCE (2015)

Article Biochemical Research Methods

Twin-column CaptureSMB: A novel cyclic process for protein A affinity chromatography

Monica Angarita et al.

JOURNAL OF CHROMATOGRAPHY A (2015)

Article Biotechnology & Applied Microbiology

Perspectives on integrated continuous bioprocessing - opportunities and challenges

Andrew L. Zydney

CURRENT OPINION IN CHEMICAL ENGINEERING (2015)

Article Biotechnology & Applied Microbiology

Design of high productivity sequential multi-column chromatography for antibody capture

Candy K. S. Ng et al.

FOOD AND BIOPRODUCTS PROCESSING (2014)

Article Biotechnology & Applied Microbiology

QbD/PAT for bioprocessing: moving from theory to implementation

Anurag S. Rathore

CURRENT OPINION IN CHEMICAL ENGINEERING (2014)

Article Computer Science, Interdisciplinary Applications

Fast and accurate parameter sensitivities for the general rate model of column liquid chromatography

Andreas Puettmann et al.

COMPUTERS & CHEMICAL ENGINEERING (2013)

Article Biochemical Research Methods

Optimising the design and operation of semi-continuous affinity chromatography for clinical and commercial manufacture

James Pollock et al.

JOURNAL OF CHROMATOGRAPHY A (2013)

Article Biochemical Research Methods

Design of high productivity antibody capture by protein A chromatography using an integrated experimental and modeling approach

Candy K. S. Ng et al.

JOURNAL OF CHROMATOGRAPHY B-ANALYTICAL TECHNOLOGIES IN THE BIOMEDICAL AND LIFE SCIENCES (2012)

Article Biotechnology & Applied Microbiology

Quality by design for biopharmaceuticals

Anurag S. Rathore et al.

NATURE BIOTECHNOLOGY (2009)

Article Computer Science, Interdisciplinary Applications

About regression-kriging: From equations to case studies

Tomislav Hengl et al.

COMPUTERS & GEOSCIENCES (2007)