Search results for " screening"

Article Optimization of Protein Expression in Escherichia Coli
May 01, 2015 By Siavash Bashiri, David Vikström, Nurzian Ismail BioPharm International Volume 28, Issue 5 Production of proteins for manufacturing therapeutics and pharmaceuticals is a c…

Article Quality by Design and Extractable and Leachable Testing
Gross toxicity screening should also be confirmed for plastic and elastomeric components, such as that provided by USP Biological Evaluation Reactivity Tests, In Vivo (3), confirming the plastic meet…

Article Viral Clearance Challenges in Bioprocessing
Equipment and process failures, such as inadequate raw material screening or failure of an upstream inactivation method, particularly those that go undetected, are also a concern with respect to poten…

Article Analyzing Proteins Using SEC, MALS, and UHPLC
“While this issue is not difficult to overcome, generally a range of SEC columns is required for screening samples, and when working on the extremes of the column (total exclusion for very big protein…

Article Challenges in Analytical Method Development and Validation
Experts give insight on method transfer, QbD, and regulations for analytical method development and validation for biopharmaceuticals. The manufacture of biopharmaceuticals presents …

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…

Article 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…

Article 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 …

Article 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…

Article 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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