Search results for " drug" in Articles / App Notes
Article
Are You in Control of the Quality of Your mAbs?
…develop and qualify assays for monoclonal antibodies (mAbs) and other therapeutic proteins to ensure drug quality.
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Automating the Biomanufacturing Process
“Integrated systems help deliver the right materials to the floor in the right quantity to match the needs of the customer in terms of drug product delivery,” he states.
However, Lebl sees a need …
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The Good and Bad of Biosimilars
A number of companies have found success in the biosimilars market, having experience in biological drug manufacture, financial muscle, and brand recognition. You will be facing steep competition whil…
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Biomanufacturing: The Cost of Unskilled Workers
First, a 2018 report from BioPlan Associates estimates there are well over 10,000 therapeutics in R&D, both drugs (chemical substance pharmaceuticals) and biopharmaceuticals (biotechnology-derived pha…
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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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Article
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…