Tag: <span>bioreactor</span>

Cell Engineering Blocks Cell Stress and Improves Biotherapeutic Production

Within the biopharmaceutical industry, mammalian cell culture is extensively used to manufacture a various biopharmaceutics uncluding antibodies, interferons, hormones, crythropoietin, clotting factors, immunoadhesins, and vaccines. The market for monoclonal antibodies (MAbs) alone is expected to grow 30% a year and reach sales of nearly $6.5 billion in 2004. The vast majority of these biotherapeutics are secreted glycoproteins obtained from mammalian cell lines such as: Chinese hamster ovary (CHO), human embryonic kidney 293 (HEK-293 or 293). NS0, and baby hamster kidney (BHK). As is the goal with most commercial products, biotechnologists strive to generate these valuable proteins in the highest yields possible in order to utilize mammalian bioreactor facilities efficiently…

Read MoreCell Engineering Blocks Cell Stress and Improves Biotherapeutic Production

Biologics Production

apoptosis bioreactor cell cycle cell stress cellular engineering mammalian cell culture productivity

Biotherapeutics from Transgenic Porcine Sources: Bioprocessing Approaches and Challenges

The biopharmaceutical manufacturing sector is rapidly gearing up production capacity to satisfy the steadily escalating global demand for complex biologics to combat a number of treatable illnesses. Frequently, the biotherapeutics in demand are too complicated to be chemically synthesized and thus are beyond the reach of traditional pharmaceutical approaches. To effectively address this issue, these products must be developed and produced using viable and robust biological systems…

Read MoreBiotherapeutics from Transgenic Porcine Sources: Bioprocessing Approaches and Challenges

Biologics Production Manufacturing

bioreactor mammalian cell culture recombinant biologics scale-up transgene expression transgenesis transgenic porcine bioreactors transgenic production

Comparison of a Static Process and a Bioreactor-based Process for the GMP Manufacture of Autologous Xcellerated T Cells for Clinical Trials

Xcyte Therapies has recently introduced a bioreactor-based process for the GMP manufacture of autologous activated T cells, Xcellerated T Cellsâ„¢, for clinical trials. Using a single customized disposable 20-L Cellbagâ„¢ with a working volume of 10 L on a customized Wave Bioreactor platform (Wave Biotech, Bridgewater, NJ), the Xcellerateâ„¢ III Process has supplanted the 60-L static Xcellerate II Process that used 60 bags cultured in a standard incubator. Compared to the Xcellerate IIâ„¢ Process, the Xcellerate III Process significantly reduces the overall labor, the number of culture containers, bag spikes, and sterile connections required, as well as reducing the process volume and the cost of goods, while more than quadrupling the final cell density and doubling the facility capacity. These process improvements are achieved without compromising final product composition or quality…

Read MoreComparison of a Static Process and a Bioreactor-based Process for the GMP Manufacture of Autologous Xcellerated T Cells for Clinical Trials

Biologics Production Manufacturing

autologous cell therapy autologous T-cells bioreactor contract manufacturing GMP T-cells

Bioreactor Process Selection for Large-Scale Manufacture of Monoclonal Antibodies — Tradeoffs and Recommendations

Bioreactor productivities are highly dependent on the process used to cultivate mammalian cells. These productivities directly affect the manufacturing plant capacity, and thereby the economics of production of monoclonal antibodies (MAbs). Historically, companies have chosen bioreactor process strategies that emphasize simplicity of scale-up at the expense of productivity, and conducted manufacturing using well-characterized and relatively straightforward batch processes. Such processes have successfully produced small or moderate quantities (ranging from ~100 g to ~ 1 kg per lot) of the desired antibody. Given the anticipated demand for large-scale quantities of MAbs (and the high stakes for the companies investing in these new biological entities), it is worthwhile to revisit these past selection strategies and see if — and under what conditions — they remain optimal today…

Read MoreBioreactor Process Selection for Large-Scale Manufacture of Monoclonal Antibodies — Tradeoffs and Recommendations

Biologics Production Manufacturing

batch processing bioreactor bioreactor process strategy continuous perfusion fed-batch monoclonal antibody scale-up

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