Search results for " degradation"

Article Modeling the Degradation of mAb Therapeutics
Kinetic modeling can be an effective tool for establishing product stability, offering a deeper understanding of these processes and allowing developers to mitigate the risk of product degradation dur…

Article Implementation of Raw Material Control Strategies in the Manufacture of Single-Use Bioprocessing Containers
Jan 01, 2015 By Sara Ullsten, Shujian Yi, Jeffrey Carter, Eva Lindskog, Pokon Ganguli, Hernan Parma, Eva Blanck  This article discusses efforts to limit polymer degradation without significant…

Article PDA's technical report for biotech cleaning validation
The report also considers the effect of degradation of the active on cleaning-validation practices and the widespread use of nonspecific methods, such as total organic carbon (TOC) and total protein, …

Article Bioterminology: A Guide to the Biopharmaceutical Lexicon
A defined characteristic of a given product; stability profile means the types of chemical degradations, rates, and expected shelf life that characterize a product.  stabilizer A chemical additiv…

Article Detecting Protein Aggregates and Evaluating their Immunogenicity
Aggregation risk factors Certain manufacturing stages influence the risk of chemical degradation, which increases the risk of physical degradation and the formation of aggregates. “These stages in…

Article Using Multiple Techniques in Biosimilar Analysis
This can aid in understanding the different degradation pathways that might be in play, another factor that is a key element of a comparability study. Overall, the application of multiple technique…

Article Impact of Manufacturing-Scale Freeze-Thaw Conditions on a mAb Solution
(38), wherein slow thawing conditions caused higher protein degradation and loss of activity (38). One key finding from this work is that fast freezing followed by slow thawing resulted in g…

Article Perfusion in the 21st Century
Constantly removing the product from the bioreactor reduces the retention time of the protein, a key improvement under production conditions that facilitate aggregation and degradation of the biologic…

Article Re-use of Protein A Resin: Fouling and Economics
Factors affecting resin underperformance Underperformance of a Protein A resin over re-use can be a result of ligand leaching or degradation, occludence of the pores with a reduction in available …

Article Challenges in Analytical Method Development and Validation
The new FDA draft guidance recommends that forced degradation samples or samples containing pertinent product-related impurities should be analyzed at both labs for a stability indicating method. For …

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