Search results for " stability testing" in Articles / App Notes

Article A Platform Approach for the Identity Testing of Multi-Component Cell-Culture Media
Data acquired from osmolality, glucose, and folic acid tests provides useful information for the specific identification of cell-culture media. By Satish Mallya, Benjamin Lay, Lihong McAleer, Alexa…

Article Microbiological Testing: Time is of the Essence
Pressures to accelerate current and next-gen therapies are challenging traditional microbiological testing methods. By Cynthia A. Challener Effective microbiological testing during biopharmace…

Article Evaluating Surface Cleanliness Using a Risk-Based Approach
Evaluating Surface Cleanliness Using a Risk-Based Approach Rinse sample analysis or visual inspection can be correlated to surface cleanliness to replace surface sampling. By Elizabeth Rivera…

Article Eliminating Residual Impurities Starts with a Strategic Plan
Eliminating Residual Impurities Starts with a Strategic Plan Identifying the source, assessing the risk, and removing residual impurities requires a strategic approach. By Cynthia A. Ch…

Article A Risk-Based Genetic Characterization Strategy for Recombinant CHO Cell Lines Used for Clinical and Commercial Applications
The authors describe the ways in which manufacturers can mitigate the risks related to the integrity of recombinant transgenes expressed in CHO cells. By Luhong He, Christopher Frye Abstract …

Article Tackling Analytical Method Development for ADCs
New analytical methods are needed for each of these new classes, both for characterization of the chemistry and release and stability testing,” says McDermott. In addition, as more products make i…

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 Putting Viral Clearance Capabilities to the Test
Process understanding and careful assessment of risks are essential in developing viral clearance programs. By Rita C. Peters nobeastsofierce/Shutterstock.com  …

Article Best Practices in Qualification of Single-Use Systems
The author discusses the current best practices in technical qualification of single-use systems. By Weibing Ding, PhD Single-use technology has been around for approximately two decades if …

Article Implementation of Raw Material Control Strategies in the Manufacture of Single-Use Bioprocessing Containers
The authors review efforts to limit polymer degradation without significantly impeding cell growth. Jan 01, 2015 By Sara Ullsten, Shujian Yi, Jeffrey Carter, Eva Lindskog, Pokon Ganguli, Her…

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