Integrated Continuous Biomanufacturing: Industrialization on the Horizon

Farid, Suzanne S.

doi:10.1002/biot.201800722

Cited by 15 publications

(18 citation statements)

References 11 publications

(15 reference statements)

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“…For instance, monoclonal antibodies continue their march on the markets, and the optimized so-called bio-better versions of existing biologies are gaining ground too (Eissa, 2017;Farid, 2019;Hummel et al, 2018;Somasundaram et al, 2018;Walsh, 2014). Many countries regard the biopharmaceutical industry as one of the strategic industries for national development, and continuously increase policy support and capital investment in the biopharmaceutical industry (Farid, 2019;Hsu et al, 2005;Kadam et al, 2016;Kensaku et al, 2019;Langer & Rader, 2017;Rai, 2002;Somasundaram et al, 2018;Valérie et al, 2010;Walsh, 2014). Therefore, biopharmaceutical industry is booming and half of the world's pharmaceuticals are biosynthesized in modern industry.…”

Section: Introductionmentioning

confidence: 99%

“…Modern biopharmaceutical industry is marked by the establishment of Genentech biopharmaceutical company on April 7, 1976 (Crunkhorn, 2014;Eissa, 2017;Farid, 2019;Hummel et al, 2018;Kadam et al, 2016;Kensaku et al, 2019;Maa & Prestrelski, 2000;Shimaoka & Springer, 2003;Somasundaram et al, 2018;Walsh, 2014). The biopharmaceutical industry becomes one of the promising industries in the 21st century.…”

Section: Introductionmentioning

confidence: 99%

“…Biopharmaceutical industry is now characterized by high technology, high investment, high risk, high profitability, and long cycle. It is one of the most active and fastest growing fields in bioengineering application and development (Eissa, 2017;Farid, 2019;Huang et al, 2011;Hummel et al, 2018;Kadam et al, 2016;Kensaku et al, 2019;Somasundaram et al, 2018;Walsh, 2014;Zhang et al, 2007). For instance, monoclonal antibodies continue their march on the markets, and the optimized so-called bio-better versions of existing biologies are gaining ground too (Eissa, 2017;Farid, 2019;Hummel et al, 2018;Somasundaram et al, 2018;Walsh, 2014).…”

Section: Introductionmentioning

confidence: 99%

“…It is one of the most active and fastest growing fields in bioengineering application and development (Eissa, 2017;Farid, 2019;Huang et al, 2011;Hummel et al, 2018;Kadam et al, 2016;Kensaku et al, 2019;Somasundaram et al, 2018;Walsh, 2014;Zhang et al, 2007). For instance, monoclonal antibodies continue their march on the markets, and the optimized so-called bio-better versions of existing biologies are gaining ground too (Eissa, 2017;Farid, 2019;Hummel et al, 2018;Somasundaram et al, 2018;Walsh, 2014). Many countries regard the biopharmaceutical industry as one of the strategic industries for national development, and continuously increase policy support and capital investment in the biopharmaceutical industry (Farid, 2019;Hsu et al, 2005;Kadam et al, 2016;Kensaku et al, 2019;Langer & Rader, 2017;Rai, 2002;Somasundaram et al, 2018;Valérie et al, 2010;Walsh, 2014).…”

Section: Introductionmentioning

confidence: 99%

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The Current Status, Trend, and Development Strategies of Chinese Biopharmaceutical Industry With a Challenging Perspective

Zhang

Liu

2020

SAGE Open

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Biopharmaceutical technology is one of the most promising biotechnologies in the world. With the development of modern biotechnology, biopharmaceuticals are thriving and developing rapidly as a global high-tech biotechnology industry, bringing the unprecedented market prospects to biopharmaceuticals in China and the world. Today, world is witnessing that Chinese biopharmaceutical industry is booming and growing up. The national biopharmaceutical industry of China, especially the development and industrialization of biological medicines with genetic engineering drugs as its core fields, has already reached a certain market scale after over 20 years of development. The biopharmaceutical industry will be one of the most active economic sectors in China, whereas the biotechnological revolution with modern biopharmaceutical technology has become the lifeblood of maintaining human health and food safety in the future. The article systematically analyzed and evaluated the current status and trend and explored the main existing problems of Chinese biopharmaceutical industry with some development strategies in a challenging perspective. It probes into Chinese biopharmaceutical industry and its bases too. The future development prospects of Chinese national biopharmaceutical industry are much optimistic but challenging.

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Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

The Current Status, Trend, and Development Strategies of Chinese Biopharmaceutical Industry With a Challenging Perspective

Zhang

Liu

2020

SAGE Open

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“…Today, production of biological products is primarily based on batch operations where each unit operation is completed in sequence. The transition from these constitutive batch processes to continuous manufacture in which the product moves directly from one unit operation to the next, has been of growing interest within the bioprocessing community in recent years (Farid, 2019). Several benefits of moving to continuous processes can be listed due to the possibility of keeping production organisms in high producing states for longer time.…”

Section: Introductionmentioning

confidence: 99%

Single-Cell Technologies to Understand the Mechanisms of Cellular Adaptation in Chemostats

Wright

Rønnest

Sonnenschein

2020

Front. Bioeng. Biotechnol.

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There is a growing interest in continuous manufacturing within the bioprocessing community. In this context, the chemostat process is an important unit operation. The current application of chemostat processes in industry is limited although many high yielding processes are reported in literature. In order to reach the full potential of the chemostat in continuous manufacture, the output should be constant. However, adaptation is often observed resulting in changed productivities over time. The observed adaptation can be coupled to the selective pressure of the nutrient-limited environment in the chemostat. We argue that population heterogeneity should be taken into account when studying adaptation in the chemostat. We propose to investigate adaptation at the single-cell level and discuss the potential of different single-cell technologies, which could be used to increase the understanding of the phenomena. Currently, none of the discussed single-cell technologies fulfill all our criteria but in combination they may reveal important information, which can be used to understand and potentially control the adaptation.

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Converting a mAb downstream process from batch to continuous using process modeling and process analytical technology

Chen

Shi

et al. 2022

Biotechnology Journal

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The biopharmaceutical market is driving the revolution from traditional batch processes to continuous manufacturing for higher productivity and lower costs. In this work, a batch mAb downstream process has been converted into an integrated continuous process with the combination of multiple techniques. For process intensification, two batch mode unit operations (protein A capture chromatography, ultrafiltration/diafiltration) were converted into continuous ones; for continuity, surge tanks were used between adjacent steps, and level signals were used to trigger process start or stop, forming a holistic continuous process. For process automation, manual operations (e.g., pH and conductivity adjustment) were changed into automatic operation and load mass was controlled with process analytical technology (PAT). A model-based simulation was applied to estimate the loading conditions for the continuous capture process, resulting in 21% resin capacity utilization and 28% productivity improvement as compared to the batch process. Automatic load mass control of cation exchange chromatography (CEX) was achieved through a customized in-line protein quantity monitoring system, with a difference of less than 1.3% as compared to off-line analysis. Total process time was shortened from 4 days (batch process) to less than 24 hours using the continuous downstream process with the overall productivity of 23.8 g mAb per day for the bench-scale system. Comparable yield and quality data were obtained in three test runs, indicating a successful conversion from a batch process to a continuous process. The insight of this work could be a reference to other similar situations.

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Integrated Continuous Biomanufacturing: Industrialization on the Horizon

Cited by 15 publications

References 11 publications

The Current Status, Trend, and Development Strategies of Chinese Biopharmaceutical Industry With a Challenging Perspective

The Current Status, Trend, and Development Strategies of Chinese Biopharmaceutical Industry With a Challenging Perspective

Single-Cell Technologies to Understand the Mechanisms of Cellular Adaptation in Chemostats

Converting a mAb downstream process from batch to continuous using process modeling and process analytical technology

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