Search results for " contamination" in Articles / App Notes
Article
Biomanufacturing: Demand for Continuous Bioprocessing Increasing
On the other hand, perfusion processing is now significantly less complex, less prone to contamination, and more readily scalable than previously. Negative assessments from within the industry of cont…
Article
Design Considerations for a Commercial Cell and Gene Therapy Facility
Single-use systems are technologies that are widely used in the bioprocessing and blood processing industries to protect product from contamination, and these systems are also appropriately sized for …
Article
A Plastic Pipeline for Commercial Bioprocessing?
…s, the reduction or elimination of cleaning steps and cleaning validation, and a lower risk of cross contamination are recognized as benefits of single-use systems compared with traditional stainless…
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Cleaning Protein A Resins with 1 M NaOH
The presence of cell culture nutrients in the harvest feed loaded on the capture column also exposes the protein A step to increased risk of microbial contamination. Historically, protein A resins hav…
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Impurity Testing of Biologic Drug Products
“Historically, contamination with trace amounts of metals was a problem leading to aggregation of therapeutic proteins, which can cause significant changes in efficacy, but understanding of the phenom…
Article
Platform Technologies Improve Protein Expression
“High-quality, defined, animal-free reagents and cell-culture products help biomanufacturers eliminate the risk of contamination that has been associated with animal- and human-serum-derived media,” a…
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How to Address Bioburden Challenges: Insights and Tips
Bioburden control is an area of serious concern for anyone making mAbs or other biologicals. Manufacturers’ efforts to avoid microbial contamination are today being complemented by developments from…
Article
Process Chromatography: Continuous Optimization
Improved resin chemistries and customized separation solutions are enabling more efficient separations.
By Cynthia A. Challener
Cell-culture and fermentation are high-…
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Managing Residual Impurities During Downstream Processing
Increased understanding of potential impurities has spurred efforts to standardize monitoring procedures.
By Cynthia A. Challener
Manufacture of protein and other biologic drug substances via …
Article
Improving Process-Scale Chromatography
Advances in technology are increasing the productivity and efficiency of commercial-scale chromatography bioprocesses.
By Cynthia Challener, PhD
Chromatography is a crucial step in the purif…