Search results for " documentation"
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Real-Time Characterization of Biotherapeutics and Comparability of Biosimilars
Real-Time Characterization of Biotherapeutics and Comparability of Biosimilars
A major advantage of SPR-based analysis is its ability to estimate the association and dissociation rate constants, an …
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A Look into the Future of Biopharmaceutical Quality
A Look into the Future of Biopharmaceutical Quality
Quality experts share insights on what the future may hold regarding regulatory quality requirements for biopharmaceuticals.
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The Challenge of Disruptive Technologies in Bioprocessing
Customers are demanding overall efficient, cost-effective solutions, faster, just-in-time service and delivery, supply chain logistics, full [good manufacturing practice] GMP documentation, high consi…
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Biopharma Seeks Balance
Biopharma Seeks Balance
Biopharma companies can balance competing demands from patients, investors, and regulators by keeping a focus on science.
By Rita C. Peters
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Making the Move to Continuous Chromatography
Making the Move to Continuous Chromatography
Early adopters are benefiting from lower costs and increased productivity.
By Cynthia A. Challener
Tashatuvango/Shu…
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FDA Framework Spurs Advanced Therapies
Greater clarity on the application of existing regulations will accelerate development of cell and gene therapies.
By Cynthia A. Challener
Ibreakstock/Shutterstock.co…
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Reliability Rooms and the Move to Proactive Supply Chain Management
Reliability Rooms and the Move to Proactive Supply Chain Management
Cross-functional reliability rooms identify risk and planning metrics, provide insights for production forecasts, and predict tren…
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Asked and Answered: Your Questions on Ion-Exchange Chromatography
On May 17, 2017, Marianne Carlsson presented the webinar, “Tips for Successful Ion Exchange Chromatography.” After the webinar, Marianne and a panel of R&D scientists participated in a live questio…
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Protein Purification Questions and Answers from ÄKTA Club Web Chat
Do you have recurring discussions in your lab that you need input on? Or do you need support to get on with your protein purification? Around 40 protein purifiers joined our latest ÄKTA club we…
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Ensuring Sterility in Small-Scale Production
In other words, the environment must be maintained and monitored with the recommendations specified in the documentation governing aseptic processing.
Properly maintaining an environment suitable …