Search results for " drug"
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Why, Why, Why…ELISA? A Look at the Benchmark HCP Assay
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Biologics developers and manufacturers demand an accurate and reliable assay for host cell protein (HCP) quantitation. Let’s take a close look at why analytica…
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Sensitive and Reproducible SPR-Based Concentration and Ligand-Binding Analyses
This article focuses on concentration assays used for drug product characterization and quality control.
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Article
Supply Chain Challenges for Single-Use Systems
Changes need to be managed together with our suppliers, because this can have an impact on our operations and more importantly, on those of drug manufacturers.
Pora (Pall): From an industry level …
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Biopharmaceutical Process Development: 2018 Lessons and 2019 Predictions
…Techniques: Get the Right Purity/Yield of Protein
• Impurity Testing of Biologic Drug Products
• Tools and Solutions for Separation of Charged mAb Variants
• Modern Manufacturing …
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Achieving Process Balance with Perfusion Bioreactors
Advances in single-use technologies, sensors, and cell retention systems facilitate processes designed for the long run.
By Cynthia A. Challener
MG/Stock.Adobe.com
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FDA Seeks to Enhance Manufacturing of Cell and Gene Therapies
With more than 100 investigational new drug applications (INDs) filed last year for gene-therapy products and multiple R&D programs underway, FDA seeks to emphasize the challenges of developing and va…
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Videos! SPR Applications in Protein Characterization
In these exclusive videos from the Biacore Analytical, Comparability and QC Symposium, Vienna, November 2017, industry thought-leaders share insights, tips, and techniques that illuminate how SPR with…
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A Look into the Future of Biopharmaceutical Quality
I think this phenomenon is more of an issue today than in the past because science innovations are occurring at a much more rapid pace and affecting all aspects of the drug product lifecycle than 20 y…
Article
Sensitive and Reproducible SPR-Based Concentration and Ligand-Binding Analyses
This article focuses on concentration assays associated with late-stage development and biotherapeutic drug chemical manufacturing and control.
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Article
The Challenge of Disruptive Technologies in Bioprocessing
…e an effective way to reduce non-core activities, address buffer bottleneck challenges, and focus on drug manufacturing, Moore asserts. “It is important to think about the biomanufacturing strategy e…