Integrated continuous biomanufacturing platform with ATF perfusion and one column chromatography operation for optimum resin utilization and productivity

Kamga, Mark-Henry; Cattaneo, Maurizio; Yoon, Seongkyu

doi:10.1080/10826068.2018.1446151

Cited by 24 publications

(17 citation statements)

References 28 publications

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“…This process resulted in increased productivity and reduced resin and buffer requirements compared to a batch process (Gjoka et al, 2017). In another study, an integrated continuous biomanufacturing process using perfusion bioreactor culture with ATF and one-column continuous chromatography (OCC) was used to produce therapeutic mAbs and achieved an 80% enhancement in productivity (Kamga et al, 2018).…”

Section: Integrated Continuous Bioprocessingmentioning

confidence: 99%

Recent Developments in Bioprocessing of Recombinant Proteins: Expression Hosts and Process Development

Tripathi

Shrivastava

2019

Front. Bioeng. Biotechnol.

369

243

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Infectious diseases, along with cancers, are among the main causes of death among humans worldwide. The production of therapeutic proteins for treating diseases at large scale for millions of individuals is one of the essential needs of mankind. Recent progress in the area of recombinant DNA technologies has paved the way to producing recombinant proteins that can be used as therapeutics, vaccines, and diagnostic reagents. Recombinant proteins for these applications are mainly produced using prokaryotic and eukaryotic expression host systems such as mammalian cells, bacteria, yeast, insect cells, and transgenic plants at laboratory scale as well as in large-scale settings. The development of efficient bioprocessing strategies is crucial for industrial production of recombinant proteins of therapeutic and prophylactic importance. Recently, advances have been made in the various areas of bioprocessing and are being utilized to develop effective processes for producing recombinant proteins. These include the use of high-throughput devices for effective bioprocess optimization and of disposable systems, continuous upstream processing, continuous chromatography, integrated continuous bioprocessing, Quality by Design, and process analytical technologies to achieve quality product with higher yield. This review summarizes recent developments in the bioprocessing of recombinant proteins, including in various expression systems, bioprocess development, and the upstream and downstream processing of recombinant proteins.

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Section: Integrated Continuous Bioprocessingmentioning

confidence: 99%

Recent Developments in Bioprocessing of Recombinant Proteins: Expression Hosts and Process Development

Tripathi

Shrivastava

2019

Front. Bioeng. Biotechnol.

369

243

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“…An intensified seed culture scheme to enhance cell densities prior to the production bioreactor, such as using enriched seed culture medium, could be an efficient strategy for increasing manufacturing capacity without modifying the production bioreactor, make fed‐batch processes highly productive and may enable flexibility of manufacturing capacity with limited volumetric capacity 9–11 . Perfusion cell culture is another process intensification strategy, with the potential to achieve higher cell density and productivity, that has also attracted increasing interest, and been adopted in biopharmaceutical manufacturing 12,13 …”

Section: Technologies For Legacy Process Improvementmentioning

confidence: 99%

Overcoming challenges of improving legacy biopharmaceutical processes

Gao¹,

Gervais²

2021

J of Chemical Tech & Biotech

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Continuous process improvement of biopharmaceutical processes is an expectation of the current regulatory environment (e.g. ICH Q8 and Q10), and extends to older products as well as new licences. Particularly in the case of older products, process changes are also often simply required to improve process efficiency, to facilitate easier manufacture and to update materials such as chromatography resins and filters that may become unavailable due to age. These older processes, or legacy processes, present unique challenges for process improvement. This paper discusses the challenges and strategies of implementing changes and new technologies for improving legacy manufacturing processes, and outlines the issues to be addressed during process redevelopment and validation, including product and process characterisation and particular regulatory constraints to ensure product profile and quality are maintained when making process changes. Case studies are presented, with a focus on adaptation of single‐use technologies for commercial biopharmaceutical processes. © 2021 Society of Chemical Industry (SCI).

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“…The integration of continuous downstream operations with perfusion bioreactors have been reported in previous studies. 6,32,33 However, until now only a few end-to-end ICBs have been presented ( Table 2)…”

Section: Process Comparison With Other Icb Platformsmentioning

confidence: 99%

Model‐based design and control of a small‐scale integrated continuous end‐to‐end mAb platform

Gomis-Fons

Schwarz

Zhang

et al. 2020

Biotechnology Progress

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A continuous integrated bioprocess available from the earliest stages of process development allows for an easier, more efficient and faster development and characterization of an integrated process as well as production of small-scale drug candidates. The process presented in this article is a proof-of-concept of a continuous end-to-end monoclonal antibody production platform at a very small scale based on a 200 ml alternating tangential flow filtration perfusion bioreactor, integrated with the purification process with a model-based design and control. The downstream process, consisting of a periodic twin-column protein A capture, a virus inactivation, a CEX column and an AEX column, was compactly implemented in a single chromatography system, with a purification time of less than 4 hr. Monoclonal antibodies were produced for 17 days in a high cell density perfusion culture of CHO cells with titers up to 1.0 mg/ml. A digital twin of the downstream process was created by modelling all the chromatography steps. These models were used for real-time decision making by the implementation of control strategies to automatize and optimize the operation of the process. A consistent glycosylation pattern of the purified product was ensured by the steady state operation of the process. Regarding the removal of impurities, at least a 4-log reduction in the HCP levels was achieved. The recovery yield was up to 60%, and a maximum productivity of 0.8 mg/ml/day of purified product was obtained.

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Integrated continuous biomanufacturing platform with ATF perfusion and one column chromatography operation for optimum resin utilization and productivity

Cited by 24 publications

References 28 publications

Recent Developments in Bioprocessing of Recombinant Proteins: Expression Hosts and Process Development

Recent Developments in Bioprocessing of Recombinant Proteins: Expression Hosts and Process Development

Overcoming challenges of improving legacy biopharmaceutical processes

Model‐based design and control of a small‐scale integrated continuous end‐to‐end mAb platform

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