Search results for " drug" in Articles / App Notes
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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…
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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.
Read the article here.
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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…
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Automation Trend in Fill/Finish Reduces Contamination Risk
The stability of aseptically filled drugs will be affected by a variety of factors. Because aseptic filling requires close coordination and involves complex interaction between personnel, sterilized p…
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Exotoxin Clearance from mAb Samples in a Two-Step Chromatography Process
A heat-stable exotoxin can remain as a contaminant of a drug substance throughout the whole manufacturing process, with the risk of adversely affecting patients’ health. One such toxin is cereulide …
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What's in Your SOP?
What’s in Your SOP?
SOPs need to reflect a company’s specific manufacturing or other operations, says Susan Schniepp, distinguished fellow at Regulatory Compliance Associates.
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Impact of Media Components on CQAs of Monoclonal Antibodies
The authors review how media components modulate the quality of monoclonal antibody products.
By Anurag Rathore, Rajinder Kaur, Dipankar Borgayari
Recombinant protein products have…
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Managing Risk in Biomanufacturing
With patients’ lives dependent on a continuous supply of high-quality drugs and vaccines, it is essential to have consistency within the industry on how to manage risks. Today’s business environment r…
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Extractables Studies for Single Use Systems Used in ADC Manufacturing, Part 1
Single‑use (SU) systems have great potential in antibody‑drug conjugates (ADC) manufacturing. The use of organic solvents in the ADC process might , however, raise questions about potential leac…