Search results for " monoclonal" in Articles / App Notes
Article
Reimagining Affordable Biosimilars
Advances in preclinical development
Analytics
The complexity of biotherapeutic molecules, in particular monoclonal antibodies (mAbs), lends themselves to fascinating targets for analytical…
Article
Scaling a mAb Production Process to Xcellerex Bioreactors
This article discusses moving a monoclonal antibody (mAb) production process from a microscale bioreactor to the Xcellerex XDR single-use platform.
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Securing Today’s Biomanufacturing Supply Chain Using Transformative Supply
Though monoclonal antibodies are expected to continue dominating the market, a more diversified pipeline that includes, for example, DNA and RNA molecules and cell and gene therapies, is anticipated a…
Article
Methods Accelerate Biosimilar Analysis
Mirror image of peptide maps of reduced/alkylated and endo-Lys C digested monoclonal antibody product lots (Upper: Innovator product; Lower: Biosimilar product).
Such a quantitative approach, i…
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Tools and Processes for Mature and Emerging Therapies
While technology advances for more traditional biologic-based drugs such as monoclonal antibodies are evolutionary, the processing requirements for emerging cell therapies and gene therapies may requi…
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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…