Search results for " monoclonal"
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Addressing the Complex Nature of Downstream Processing with QbD
When it comes to monoclonal antibodies, MacDonald says that viral clearance processes are “widely known and understood”, with most platforms being developed for effective and orthogonal approaches for…
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Leveraging Computational Models of Glycosylation for Biopharma QA
Close collaboration between academic and industrial groups is vital to ensuring glycosylation models are fit for deployment.
By Ioscani Jiménez del Val
Good Studio/S…
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Are You in Control of the Quality of Your mAbs?
Stuart Knowling from Antibody Analytics presented how the latest innovation in surface plasmon resonance (SPR) technology has been adopted to develop and qualify assays for monoclonal antibodies (mAbs…
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Advances in Engineering of Protein-Based APIs
Today, monoclonal antibodies (mAbs) have become one of the predominant forms of protein-based biopharmaceuticals, with humanization and fully human monoclonals contributing to their increasing success…
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A Plastic Pipeline for Commercial Bioprocessing?
In January 2018, Fujifilm announced the qualification of its Saturn mAb Solutions facility in College Station, TX for cGMP production of monoclonal antibodies. The building was designed to accommodate…
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Integrated Semi-Continuous Process for mAb Production
A complete process for the production of a biopharmaceutical consists of a great number of distinct unit operations, for example, cell culture, filtration, and chromatography. Linking these differen…
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Challenges in Cell Harvesting Prompt Enhancements
The higher titers and cell densities made the initial clarification of monoclonal antibody (mAb) product more difficult, driving the need for filtration technologies that can handle the large amounts …
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Automation Trend in Fill/Finish Reduces Contamination Risk
The company installed the new filling line to meet demand for innovative biologics, including vaccines, gene therapies, oncolytic live virus-based therapies, monoclonal antibodies, and recombinant pro…
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Capacity and Performance of a Next Generation Protein A Chromatography Resin
This application note demonstrates the binding capacity and purification performance of MabSelect PrismA in comparison with its predecessor products for both polyclonal and monoclonal antibodies. An i…
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Process Development: What May Lie Ahead in 2018?
Aligning with this news, Process Development Forum readers showed strong interest in an article discussing next-generation antibodies, which are often more potent and more specific than traditional mo…