Article
Engineering, Environmental
Liqiang Shao, Chen Sheng, Mengxiang Lu, Ying Yang, Ping Li
Summary: The objective of this work is to develop an advanced adsorption process to continuously recover and remove boron from brines. The adsorption and desorption performances of boron on the D403 resin were evaluated, and a cyclic adsorption and desorption process was investigated experimentally for boron recovery. A seven-column SMB process with four zones was designed and experimentally investigated, and it was found that boron can be recovered continuously from brine and a boron-rich solution can be obtained. The proposed multicolumn SMB process achieved simultaneous recovery and removal of boron from brine.
JOURNAL OF WATER PROCESS ENGINEERING
(2023)
Article
Biotechnology & Applied Microbiology
Keith Gillette, Marc Bisschops, Mark Schofield
Summary: The maturation of the bioprocessing industry drives the desire to reduce manufacturing costs through process intensification. This article discusses the motivation for more productive upstream perfusion processes and their implications for downstream purification, focusing on optimizing downstream chromatography steps based on perfusion upstream. Different chromatography solutions and their possible impact on the purification process are explored.
JOURNAL OF CHEMICAL TECHNOLOGY AND BIOTECHNOLOGY
(2022)
Article
Engineering, Chemical
Tae Keun Kim, Chiara Botti, James Angelo, Xuankuo Xu, Sanchayita Ghose, Zheng Jian Li, Massimo Morbidelli, Mattia Sponchioni
Summary: The rapid growth and diffusion of biopharmaceuticals, including PEG-protein conjugates, has led to the need for stringent regulatory requirements regarding purity and clinical safety. To meet these requirements, the development of robust purification methods, such as MCSGP, plays a crucial role in improving process yield while maintaining purity specifications. By optimizing process parameters, superior performances can be achieved in the MCSGP unit compared to the batch process, leading to increased yield and productivity at fixed purity specifications.
INDUSTRIAL & ENGINEERING CHEMISTRY RESEARCH
(2021)
Article
Biotechnology & Applied Microbiology
Fuminori Konoike, Masatoshi Taniguchi, Shuichi Yamamoto
Summary: A continuous downstream process for monoclonal antibodies was developed using periodic-counter current chromatography (PCCC) for capture, a batch reactor for low pH virus inactivation (VI), and flow-through chromatography (FTC) for polish. Different runs with varying feed rates and concentrations were performed, achieving good recovery and purity values. The process was found to be flexible and stable for feed fluctuations, requiring only a few surge or pool tanks in addition to the final product pool tank.
BIOTECHNOLOGY AND BIOENGINEERING
(2023)
Article
Biochemical Research Methods
Tae Keun Kim, Abdallah Ayub Bham, Ismaele Fioretti, James Angelo, Xuankuo Xu, Sanchayita Ghose, Massimo Morbidelli, Mattia Sponchioni
Summary: Protein PEGylation is an efficient method to improve the therapeutic index of biopharmaceuticals. Multi-column Countercurrent Solvent Gradient Purification (MCSGP) has been demonstrated as an efficient process for separating PEGylated proteins, thanks to the recycling of product-containing side fractions. The study aims to elucidate the role of gradient slope in the recycling stage and its impact on the yield and productivity of MCSGP.
JOURNAL OF CHROMATOGRAPHY A
(2023)
Article
Biotechnology & Applied Microbiology
Ce Shi, Qi-Lei Zhang, Biao Jiao, Xu-Jun Chen, Ran Chen, Wei Gong, Shan-Jing Yao, Dong-Qiang Lin
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)
Review
Biochemical Research Methods
Ohnmar Khanal
Summary: Chromatography is a widely used separation method that is being transitioned from batch to continuous operation. In the biopharmaceutical industry, continuous chromatography shows great potential but also poses implementation challenges due to its complexity. Mathematical modeling and novel process analytical technologies are essential for the successful implementation of continuous chromatography.
CURRENT OPINION IN BIOTECHNOLOGY
(2022)
Article
Engineering, Chemical
Saxena Nikita, Anamika Tiwari, Deepak Sonawat, Hariprasad Kodamana, Anurag S. Rathore
Summary: This study introduces a novel approach based on reinforcement learning to separate charge variants in biopharmaceutical industry by optimizing flow rate, achieving good results in experimental validation. Compared to traditional trial and error methods, this approach shows higher efficiency in both optimization and computational aspects.
CHEMICAL ENGINEERING SCIENCE
(2021)
Article
Biochemical Research Methods
Chyi-Shin Chen, Fuminori Konoike, Noriko Yoshimoto, Shuichi Yamamoto
Summary: A rational method for designing PCCC processes based on mechanistic model simulations was developed in this study, which included iterative calculations to optimize the process. Breakthrough curves of a monoclonal antibody on different protein A resins were measured to obtain parameters for numerical simulations, which also involved the establishment of regression curves to describe process performances. Linear correlations between key parameters were identified, and linear regression curves were developed for protein A resins to aid in the design and optimization of PCCC for reducing process development time.
JOURNAL OF CHROMATOGRAPHY A
(2021)
Article
Biotechnology & Applied Microbiology
Chaoying Ding, Hiren Ardeshna, Christopher Gillespie, Marianthi Ierapetritou
Summary: This study aims to build a fully integrated continuous platform for monoclonal antibody (mAb) production and assesses the economic and ecological impacts of the process. The results show that increasing the bioreactor scale and mAb titer can decrease the operating cost per unit product, and increasing the mAb titer is more favorable in terms of ecological impacts.
BIOTECHNOLOGY AND BIOENGINEERING
(2022)
Article
Biochemical Research Methods
Tae Keun Kim, Benedetta Sechi, Juan Jose Romero Conde, James Angelo, Xuankuo Xu, Sanchayita Ghose, Massimo Morbidelli, Mattia Sponchioni
Summary: Conjugation of biopharmaceuticals to polyethylene glycol chains, known as PEGylation, is an efficient and widely used strategy to improve the properties of active molecules. The purification of PEGylated drugs is a crucial step in their manufacturing process. Single-column chromatography is commonly used in industry but has poor product recoveries. Multicolumn Countercurrent Solvent Gradient Purification (MCSGP) is a valuable solution that allows the recycling of product-containing side fractions. In this study, the optimal parameters for single-column batch purification of an industrially relevant PEGylated protein were determined and transferred to MCSGP, resulting in improved yield and productivity. Furthermore, a detailed economic analysis demonstrated the viability and flexibility of MCSGP compared to single-column purification.
JOURNAL OF CHROMATOGRAPHY A
(2022)
Article
Computer Science, Artificial Intelligence
Ziyang Han, Xusheng Qian, He Huang, Tingwen Huang
Summary: This paper proposes an efficient design method for large-scale learning tasks by using an improved GHC learning algorithm to construct MCRN, ensuring desired performance and high efficiency. Experimental results demonstrate that the proposed method outperforms some existing methods in terms of training and testing efficiencies as well as classification accuracy.
Article
Biochemical Research Methods
Yan-Na Sun, Wu -Wei Chen, Shan -Jing Yao, Dong-Qiang Lin
Summary: Continuous manufacturing in monoclonal antibody production has gained interest due to its consistent quality, high productivity, high equipment utilization, and low cost. Implementing continuous chromatography is a challenge, but chromatographic modeling can assist in process development and characterization by studying breakthrough curves and elution behaviors.
JOURNAL OF CHROMATOGRAPHY A
(2023)
Article
Biochemical Research Methods
Kamiyar Rezvani, Andrew Smith, Jannat Javed, William R. Keller, Kevin D. Stewart, Logan Kim, Kelcy J. Newell
Summary: The biopharmaceutical industry relies on high-throughput systems and strategies for biologics manufacturing process development. While these systems provide valuable data, their interpretation often requires complex data transformation and time-intensive system characterization. The use of Tecan automated liquid handling systems with RoboColumns for purification development has shown promising results, but the lack of an optimized liquid delivery system limits their performance. This study introduces a Tecan Freedom EVO high-throughput purification tool that enables continuous gradient elution capability, leading to improved performance and consistency between RoboColumns and larger column formats.
JOURNAL OF CHROMATOGRAPHY A
(2023)
Article
Biotechnology & Applied Microbiology
Chyi-Shin Chen, Kosei Ando, Noriko Yoshimoto, Shuichi Yamamoto
Summary: The proposed linear flow-velocity gradient (LFG) method increases productivity and reduces resin cost in capture chromatography. It has great potential for application in optimizing process efficiency.
BIOTECHNOLOGY AND BIOENGINEERING
(2021)
Article
Biochemical Research Methods
Jonathan Hummel, Mark Pagkaliwangan, Xhorxhi Gjoka, Terence Davidovits, Rick Stock, Thomas Ransohoff, Rene Gantier, Mark Schofield
BIOTECHNOLOGY JOURNAL
(2019)
Review
Biotechnology & Applied Microbiology
Mark Schofield
BIOTECHNOLOGY LETTERS
(2018)
Article
Biochemical Research Methods
Jonathan Hummel, Mark Pagkaliwangan, Xhorxhi Gjoka, Terence Davidovits, Rick Stock, Thomas Ransohoff, Rene Gantier, Mark Schofield
BIOTECHNOLOGY JOURNAL
(2019)
Article
Biotechnology & Applied Microbiology
Meng-Jung Chiang, Mark Pagkaliwangan, Scott Lute, Glen Bolton, Kurt Brorson, Mark Schofield
BIOTECHNOLOGY AND BIOENGINEERING
(2019)
Article
Biotechnology & Applied Microbiology
Keith Gillette, Marc Bisschops, Mark Schofield
Summary: The maturation of the bioprocessing industry drives the desire to reduce manufacturing costs through process intensification. This article discusses the motivation for more productive upstream perfusion processes and their implications for downstream purification, focusing on optimizing downstream chromatography steps based on perfusion upstream. Different chromatography solutions and their possible impact on the purification process are explored.
JOURNAL OF CHEMICAL TECHNOLOGY AND BIOTECHNOLOGY
(2022)
Article
Biochemical Research Methods
Adam L. Hejmowski, Kurt Boenning, Julio Huato, Aydin Kavara, Mark Schofield
Summary: A novel anion exchange chromatography elution method for enrichment of full AAV particles is demonstrated in this study, allowing for effective enrichment of full capsids. This approach has the potential to simplify manufacturing processes and increase scalability.
BIOTECHNOLOGY JOURNAL
(2022)