Therapeutic antibodies: Market considerations, disease targets and bioprocessing

Elvin, John; Couston, Ruairidh G.; Walle, Christopher F. van der

doi:10.1016/j.ijpharm.2011.12.039

Cited by 216 publications

(173 citation statements)

References 139 publications

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“…Thus, antibodies are well established in mainstream clinical practice as well as in research areas 20 . Additionally, in recent years, hollow-fiber membrane-based bioreactors have been reported as apt cell culture systems for therapeutic applications 9 , such as tissue engineering 21 or growing red blood cells 22 .…”

Section: Jain and Kumarmentioning

confidence: 99%

“…Modelling is increasingly being used to understand bioreactor behaviour, specifically some attempts to model hybridoma growth 23,24 and MAb production 25,26 in HFBR have been carried out. Moreover, different authors have recently proposed sophisticated mathematical equations to describe hybridoma metabolism and antibody production in batch cultures 19,20 . However, as far as we know, there are virtually no published studies that consider both hybridoma metabolism and MAb production in HFBR systems.…”

Section: Jain and Kumarmentioning

confidence: 99%

“…[19][20][21][22]. The exponents of the inhibitory terms were assumed to be the same for glucose/glutamine consumption and lactate/ammonium production, both values being found to be quite similar (n LAC = 0.10 and n AM = 0.15, respectively).…”

Section: -Evolution Of Antibody Concentration (Samples Taken From Thementioning

confidence: 99%

See 2 more Smart Citations

Diffusion and Inhibition Processes in a Hollow-fiber Membrane Bioreactor for Hybridoma Culture. Development of a Mathematical Model

Legazpi

Laca

Collado

et al. 2016

Chem.Biochem.Eng.Q.

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The performance of a hollow-fiber membrane bioreactor (HFBR) (molecular weight cut-off 30 kD, fiber surface area 2050 cm 2 ) containing a culture of hybridoma cells has been investigated. Experimental data were used as basis to develop a model of general application. Concentrations of fundamental nutrients (glucose and glutamine), inhibitory products (ammonium and lactate), and monoclonal antibodies (MAb) against bovine lactoferrin (IgG 1 ) were monitored over time. Exchange of nutrients and products occurred across the capillary surface, whereas cells and MAb remained in the extra-capillary space (ECS). A protein-free culture medium (Hybrimax) with and without antibiotics was used. In both cases, the final MAb concentration was the same; however, antibiotic presence slowed down the time to achieve this concentration. Diffusion assays have been carried out in order to support the development of a mathematical model that describes the performance of the HFBR, including mass transfer and reaction terms. Inhibition by ammonium and lactate has been considered in the kinetics, providing model results consistent with experimental data. Further research with other cell lines and/or culture media will allow to broaden the field of application of this model for general use in HFBR systems.

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Section: Jain and Kumarmentioning

confidence: 99%

Section: Jain and Kumarmentioning

confidence: 99%

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Diffusion and Inhibition Processes in a Hollow-fiber Membrane Bioreactor for Hybridoma Culture. Development of a Mathematical Model

Legazpi

Laca

Collado

et al. 2016

Chem.Biochem.Eng.Q.

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“…In the past decades, monoclonal antibody (mAb) production and application as research and diagnostic tools or as therapeutic agents for various human diseases has created a great deal of interest, which is constantly on the rise (Hagemeyer et al 2009;Siddiqui 2010;Guergova-Kuras et al 2011;Modjtahedi et al 2012;Elvin et al 2013). Apart from their recombinant forms which are generated in high producer CHO or other type of cells, most of the antibodies are produced using hybridomas, either in animals (in vivo) or in cell culture (in vitro) (Schirrmann et al 2008;Liu 2014).…”

Section: Introductionmentioning

confidence: 99%

Specific detection and quantitation of bovine IgG in bioreactor derived mouse mAb preparations

Gall-Debreceni¹,

Lázár

Kádas³

et al. 2016

Journal of Immunological Methods

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Monoclonal antibody and recombinant protein production benefits greatly from bovine serum as an additive. The caveat is that bovine serum IgG, co-purifies with mAbs and IgG Fccontaining fusion proteins and it presents a contaminant in the end products. In order to analytically validate the products, species specific reagents are needed that react with bovine IgG exclusively. Our attempts to find such commercially available reagents failed. Here, we report the production of species specific mAbs which recognize bovine IgG even in the presence of excess amount of mouse IgG. We present five mAbs: Bsi4028, Bsi4032, Bsi4033, Bsi4034 and Bsi4035 suitable to determine the presence of bovine IgG contamination via ELISA or immunoblotting in bioreactor derived mouse mAb preparations. To quantitate bovine IgG content we developed sensitive sandwich ELISAs capable to detect bovine IgG contaminant in the ng/ml (~10 -11 M/l) range. Finally, we show that bovine IgG is efficiently removed from bioreactor produced mouse mAb preparation via affinity depletion columns prepared with Bsi4028, Bsi4032, Bsi4033, Bsi4034, Bsi4035 mAbs.

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“…Monoclonal antibodies, or MAbs, make up a major portion of the rapidly growing therapeutic protein market, capturing 7 % of the nearly $600 billion sales in 2010 (Elvin et al 2013). In tandem with drug discovery, process development activities are focused on improving product quality while decreasing the cost of goods sold.…”

Section: Introductionmentioning

confidence: 99%

A simultaneous assessment metric for MAb quantity and glycan quality

et al. 2016

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As a critical quality attribute, glycosylation represents an important consideration when analyzing the success of a glycoprotein production process. Though critical, glycosylation is not the only measure of culture success; other factors, including culture size, maintenance, and productivity, are also critical. A new metric was developed to address both product quality, as measured through glycosylation, and product quantity, as measured through product concentration. A monoclonal antibody Chinese hamster ovary cell culture model system was used to assess this metric across various media formulations. In a model test system, the metric discriminated that some media supplements had a net positive impact on productivity and glycosylation, while others had a net negative impact on productivity and glycosylation.

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Therapeutic antibodies: Market considerations, disease targets and bioprocessing

Cited by 216 publications

References 139 publications

Diffusion and Inhibition Processes in a Hollow-fiber Membrane Bioreactor for Hybridoma Culture. Development of a Mathematical Model

Diffusion and Inhibition Processes in a Hollow-fiber Membrane Bioreactor for Hybridoma Culture. Development of a Mathematical Model

Specific detection and quantitation of bovine IgG in bioreactor derived mouse mAb preparations

A simultaneous assessment metric for MAb quantity and glycan quality

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