Automated Single‐Use Centrifugation Solution for Diverse Biomanufacturing Process

Mehta, Sunil

doi:10.1002/9783527673681.ch15

Cited by 10 publications

(6 citation statements)

References 5 publications

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“…This flow pattern is far from the plug flow assumption (Eq. ) inherent in FBM modeling and suggested by Mehta, and results from a strong Coriolis force at the rotational speeds (2690 and 2970 RPMs) used in this research. The Coriolis force drives flow in the direction of rotation (i.e., along the upper wall in Figure ) until it runs toward the opposing wall at an x position close to the Elutriation boundary and then turns again and runs to the bowl outlet (see this “Z” path shown with bold lines in Figure ).…”

Section: Resultsmentioning

confidence: 76%

Understanding and modeling retention of mammalian cells in fluidized bed centrifuges

Kelly

Rubin

Scully

et al. 2016

Biotechnology Progress

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Within the last decade, fully disposable centrifuge technologies, fluidized-bed centrifuges (FBC), have been introduced to the biologics industry. The FBC has found a niche in cell therapy where it is used to collect, concentrate, and then wash mammalian cell product while continuously discarding centrate. The goal of this research was to determine optimum FBC conditions for recovery of live cells, and to develop a mathematical model that can assist with process scaleup. Cell losses can occur during bed formation via flow channels within the bed. Experimental results with the kSep400 centrifuge indicate that, for a given volume processed: the bed height (a bed compactness indicator) is affected by RPM and flowrate, and dead cells are selectively removed during operation. To explain these results, two modeling approaches were used: (i) equating the centrifugal and inertial forces on the cells (i.e., a force balance model or FBM) and (ii) a two-phase computational fluid dynamics (CFD) model to predict liquid flow patterns and cell retention in the bowl. Both models predicted bed height vs. time reasonably well, though the CFD model proved more accurate. The flow patterns predicted by CFD indicate a Coriolis-driven flow that enhances uniformity of cells in the bed and may lead to cell losses in the outflow over time. The CFD-predicted loss of viable cells and selective removal of the dead cells generally agreed with experimental trends, but did over-predict dead cell loss by up to 3-fold for some of the conditions. © 2016 American Institute of Chemical Engineers Biotechnol. Prog., 32:1520-1530, 2016.

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Section: Resultsmentioning

confidence: 76%

Understanding and modeling retention of mammalian cells in fluidized bed centrifuges

Kelly

Rubin

Scully

et al. 2016

Biotechnology Progress

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“…Despite these promising aspects of counterflow centrifugal technology, there is a scarcity of information on the efficiency of this approach in cell washing and concentration. The Ksep 6000 has six processing chambers with a volume of up to 1 L each and is capable of processing a volume of up to 6000 L in a continuous fashion [88,89]. A recent study reported that the Ksep 400 performed the wash-and-concentrate process with 50 L of pluripotent stem cells in under 2 h, achieving cell recovery above 90% with no negative impact on cell viability [90].…”

Section: Chamber Inlet Designmentioning

confidence: 99%

Advances in automated cell washing and concentration

Li¹,

Kusuma²,

Driscoll³

et al. 2021

Cytotherapy

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The successful commercialization of cell therapies requires thorough planning and consideration of product quality, cost and scale of the manufacturing process. The implementation of automation can be central to a robust and reproducible manufacturing process at industrialized scales. There have been a number of washand-concentrate devices developed for cell manufacturing. These technologies have arisen from transfusion medicine, hematopoietic stem cell and biologics manufacturing where operating mechanisms are distinct from manual centrifugation. This review describes the historical origin and fundamental technologies underlying each currently available wash-and-concentrate device as well as their relative advantages and disadvantages in cell therapy applications. Understanding the specific attributes and limitations of these technologies is essential to optimizing cell therapy manufacturing.

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“…Singleuse depth filters are more common due to the commercial unavailability of single-use large-scale centrifuges (Boedeker et al, 2017). For centrifugation, kSep R single-use continuous centrifuges (kSep400 and kSep6000S) (Sartorius) were developed and successfully used for cell harvesting to purify recombinant proteins (Mehta, 2014). The Unifuge is another single-use centrifuge available for cell harvesting.…”

Section: Single-use Technologiesmentioning

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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Automated Single‐Use Centrifugation Solution for Diverse Biomanufacturing Process

Cited by 10 publications

References 5 publications

Understanding and modeling retention of mammalian cells in fluidized bed centrifuges

Understanding and modeling retention of mammalian cells in fluidized bed centrifuges

Advances in automated cell washing and concentration

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

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