Bioreactor systems for the production of biopharmaceuticals from animal cells

Warnock, James N.; Al‐Rubeai, Mohamed

doi:10.1042/ba20050233

Cited by 87 publications

(11 citation statements)

References 87 publications

(111 reference statements)

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“…4 and 15. Several detailed reviews (Castilho and Medronho 2002;Voisard et al 2003;Kompala and Ozturk 2005;Warnock and Al-Rubeai 2006;Griffiths 2001;Woodside et al 1998) have been previously published giving a deeper view of the existing cell separation techniques. The present text aims at updating or complementing this knowledge more than repeating it and is focussing on used techniques more than those at an explorative stage.…”

Section: Cell Separation Devicesmentioning

confidence: 97%

Perfusion Processes

Chotteau

2014

Cell Engineering

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The interest for perfusion is increasing nowadays. This new focus has emerged from a synergy of a demand for disposable equipment and the availability of robust cell separation device, as well as the need for higher flexibility and lower investment cost. The cell separation devices mostly used today are based on filtration, i.e. alternating flow filtration, tangential flow filtration, spin-filter, or acceleration/gravity, i.e. inclined settler, centrifuge, acoustic settler. This paper gives an introduction to the basic concepts of perfusion and its practical implementation. It reviews the actual cell separation devices and describes the approaches used in the field to develop and optimize the perfusion processes.

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Section: Cell Separation Devicesmentioning

confidence: 97%

Perfusion Processes

Chotteau

2014

Cell Engineering

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“…Protein glycosylation can potentiate biological activity, regulate the rate of clearance of the protein from the circulatory system, and influence the potential antigenicity of the protein (9)(10)(11)(12)(13)(14). The glycoforms of therapeutic glycoproteins can potentially contribute to their efficacy, stability, and safety (15)(16)(17)(18)(19)(20)(21)(22).…”

Section: Introductionmentioning

confidence: 99%

Direct Site-Specific Glycoform Identification and Quantitative Comparison of Glycoprotein Therapeutics: Imiglucerase and Velaglucerase Alfa

Hill²,

Gucinski

et al. 2014

AAPS J

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Abstract. Gaucher disease, the most common lysosomal metabolic disorder, can be treated with enzyme replacement therapy (ERT). Recombinant human glucocerebrosidase imiglucerase (Cerezyme ® ), produced in Chinese hamster ovary cells, has been used for ERT of Gaucher disease for 20 years. Another recombinant glucocerebrosidase velaglucerase alfa (VPRIV), expressed in a human fibroblast cell line, was approved by the US Food and Drug Administration in 2010. The amino acid sequence difference at residue 495 of these two products is well documented. The overall N-linked qualitative glycan composition of these two products has also been reported previously. Herein, employing our recently developed approach utilizing isobaric tandem mass tag (TMT) labeling and an LTQ Orbitrap XL electron transfer dissociation (ETD) hybrid mass spectrometer, the site-specific glycoforms of these products were identified with ETD and collision-induced dissociation (CID) spectra. The quantitative comparison of site-specific glycans was achieved utilizing higher-energy collisional dissociation (HCD) spectra with a NanoMate used as both a fraction collector and a sample introduction device. From the trypsin-digested mixture of these two products, over 90 glycopeptides were identified by accurate mass matching. In addition to those previously reported, additional glycopeptides were detected with moderate abundance. The relative amount of each glycoform at a specific glycosylation site was determined based on reporter signal intensities of the TMT labeling reagents. This is the first report of site-specific simultaneous qualitative and quantitative comparison of glycoforms for Cerezyme ® and VPRIV. The results demonstrate that this method could be utilized for biosimilarity determination and counterfeit identification of glycoproteins.

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“…Bioreactor type and process control are also important factors to consider for successful process optimization and effective process development (Butler and Meneses-Acosta, 2012). The bioreactors used for biopharmaceuticals production include stirred tank bioreactors, airlift bioreactors, bubble column bioreactors, hollow fiber bioreactors, and fixed bed and fluidized bed bioreactors (Warnock and Al-Rubeai, 2006;Jain and Kumar, 2008;Vermasvuori and Hurme, 2011;Rivas-Interián et al, 2019). Membrane bioreactors are also available commercially (miniPERM bioreactor from Vivascience and CELLine from Integra Biosciences) and are utilized for small-scale production of mAbs (Dewar et al, 2005).…”

Section: Transgenic Animalsmentioning

confidence: 99%

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

Tripathi

Shrivastava

2019

Front. Bioeng. Biotechnol.

323

198

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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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Bioreactor systems for the production of biopharmaceuticals from animal cells

Cited by 87 publications

References 87 publications

Perfusion Processes

Perfusion Processes

Direct Site-Specific Glycoform Identification and Quantitative Comparison of Glycoprotein Therapeutics: Imiglucerase and Velaglucerase Alfa

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

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