Search results for " monoclonality"
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Addressing the Complex Nature of Downstream Processing with QbD
Quality by design brings both challenges and benefits to the development of downstream processes.
By Susan Haigney
natali_mis/Stock.Adobe.com
Regulators have been en…
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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?
Better biotherapeutic characterization for improved quality control
At the recent WCBP conference in Washington, D.C., Dr. Stuart Knowling from Antibody Analytics presented how the latest innovati…
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Advances in Engineering of Protein-Based APIs
Advances in Engineering of Protein-Based APIs
New platform technologies, advanced modeling tools, and addressing patient needs are important developments.
By Cynthia A. Challener
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A Plastic Pipeline for Commercial Bioprocessing?
A Plastic Pipeline for Commercial Bioprocessing?
The maturation of single-use technologies presents commercial bioprocessing options for small-volume drug products.
By Rita C. Peters
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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
Challenges in Cell Harvesting Prompt Enhancements
Higher cell titers and cell densities have posed a challenge to cell harvesting, a crucial step in biologics manufacturing.
By Feliza Mi…
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Automation Trend in Fill/Finish Reduces Contamination Risk
Aseptic fill/finish is crucial in biopharma manufacturing and is optimized through automated technology.
By Feliza Mirasol
Aseptic filling is a crucial process in biopharmaceutical …
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Capacity and Performance of a Next Generation Protein A Chromatography Resin
MabSelect™ PrismA is a protein A resin of which both the ligand and the base matrix have been optimized. The resin exhibits improved capacity over its predecessor MabSelect SuRe™ products, while maint…
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Process Development: What May Lie Ahead in 2018?
2018 is shaping up to be an interesting year in the world of biopharmaceuticals. What have 2017 developments taught us, and what may lie ahead for biopharmaceutical drug developers and process engin…