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
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…
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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The new FDA draft guidance recommends that forced degradation samples or samples containing pertinent product-related impurities should be analyzed at both labs for a stability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 …
Article
Sterilization Trends for Single-Use Consumables
Single-use (SU) technologies increasingly find use today at all phases of the drug development cycle from preclinical to commercial manufacturing. As the biopharmaceutical market continues to …