Search results for " harvest"
Article
Mapping a Route for Cell and Gene Therapy Process Development
The productivity largely depends on the harvest titer and downstream process yield. Moreover, the product design at the molecular level, the producer cell line, and the production medium can all be li…
Article
Achieving Process Balance with Perfusion Bioreactors
Perfusion processes are generally considered to be those in which the product is continuously harvested from the bioreactor and new media is fed. These processes can be run for weeks or even months at…
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The Challenge of Disruptive Technologies in Bioprocessing
Other drivers relate to gaps in process performance, for example, “the notorious weakness of harvesting technologies in the face of the ever-increasing biomass from highly productive mammalian cell cu…
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Impact of Media Components on CQAs of Monoclonal Antibodies
Cysteine, along with temperature shift, is believed to reduce protein aggregates and increase their stability in culture harvests. The oxidized form of cysteine has been shown to reduce the formation …
Article
Being Thorough When Transferring Technology
Next-generation harvest technologies, including flocculation with cell settling and microfiltration, are being implemented, and the data are limited regarding the utility of their small-scale models. …
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Generating a Fully Processed Antibody
Cultures were inoculated at approximately 300,000 cells/mL and harvested when cell viabilities reached approximately 50%. For the single tagged antibody, titers for the individual clonal cell lines ra…
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An Integrated Approach to Ensure the Viral Safety of Biotherapeutics
…ic virus controls in the product manufacturing process:
Virus testing (bulk harvest, drug substance, drug product)
Viral clearance affored by downstream purification.
…
Article
Tools for Continuous Bioprocessing Development
Continuous perfusion holds the promise of improved product quality and consistency because of steady-state operation and because the secreted molecule does not have to be held until the end for harves…
Article
Host-Cell Protein Measurement and Control
In a typical recovery process for a therapeutic monoclonal antibody, the highest concentration of HCP is detected in the harvested cell culture fluid (HCCF), and then cleared through additional downst…
Article
Re-use of Protein A Resin: Fouling and Economics
A typical Protein A chromatography process consists of five steps: pre-equilibration and equilibration of the column; capture of the mAbs from the harvest; wash step with the selective buffer to remov…