Search results for " contamination" in Articles / App Notes

Article Modeling the Degradation of mAb Therapeutics
Modeling the Degradation of mAb Therapeutics Kinetic models can be used to study aggregation and fragmentation to help ensure stability. By Anurag S. Rathore, Rohit Bansal …

Article Achieving Process Balance with Perfusion Bioreactors
Advances in single-use technologies, sensors, and cell retention systems facilitate processes designed for the long run. By Cynthia A. Challener  MG/Stock.Adobe.com …

Article Prepare for an FDA Bioburden Inspection
Click here to read the article >> Not sure how to best approach a bioburden problem when an FDA inspection is imminent? Anastasia Lolas, former FDA Biologics License Application (BLA) revi…

Article Optimizing Late-Stage and Commercial Cell-Culture Processes
Optimizing Late-Stage and Commercial Cell-Culture Processes Late-stage and commercial biomanufacturing pose a challenge to cell-culture processing. By Feliza Mirasol …

Article Challenges in Cell Harvesting Prompt Enhancements
Challenges in Cell Harvesting Prompt Enhancements Higher cell titers and cell densities have posed a challenge to cell harvesting, a crucial step in biologics manufacturing. By Feliza Mi…

Article Understanding Validation and Technical Transfer, Part 3
Understanding Validation and Technical Transfer, Part 3 Validation ensures safe and effective biologic products that benefit the patients whose health and wellbeing depend on the therapies. Part 1 |…

Article Chromatography Scale-Up: Don’t Get Tied Down by Bed Height
Click here to read the article >>   When scaling, you can make better use of existing chromatography columns while avoiding overcapacity.  Keeping a constant residence time is a well-est…

Article Industry Adoption of Single-Use Systems Remains Low
Many of the multiple steps in the cell therapy manufacturing process remain largely unintegrated and require manual labor, and open transfers between steps increase the risk of contamination (6). …

Article 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 …

Article Process Development: What May Lie Ahead in 2018?
Also hot was a second piece on protecting against microbiological contamination over the whole manufacturing process. Regulatory issues continue to be a major concern. FDA increased its oversi…

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