Search results for " screening" in Articles / App Notes
Article
Raw Material Variability
Additional testing, batch screening, and lot-to-lot blending are often tactics employed, either at the supplier or in house.
Sometimes the supplier is a big company selling materials to many ind…
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FDA Seeks Metrics to Define Drug Quality
Manufacturing standards are considered key to preventing drug recalls and shortages.
Critical drug shortages and contaminated compounding of sterile injectables have heightened public concern a…
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Elucidating Biosimilars Characterization
The global market for biosimilar drugs has been forecasted to be $2.445 billion in 2013 according to a report by the British market-research firm, Visiongain (1). The growth corresponds to a …
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HT Multi-Product Liquid Chromatography for Characterization of Monoclonal Antibodies
…he labor needed to make and change a variety of buffers, and the capability of automation for buffer screening during method development. Despite these advantages, the final developed IEC method is p…
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QbD and PAT in Upstream and Downstream Processing
While scale-down models combined with screening and design space DOEs can be used to understand cell expansion and the cell-production bioreactor processes, full purification can be time consuming and…
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Quality by Design: A CMO's Perspective on Gaining Knowledge Faster and Better
Process characterization is often an iterative process involving parameter screening, range identification and response surface mapping. This method enables revisiting the original process development…