Search results for " contamination" in Articles / App Notes
Article
Prepare for an FDA Bioburden Inspection
Even with effective prevention, bioburden incidents can occur. A best-practices response will not only help you be prepared for any upcoming FDA inspection, it may also yield valuable insights to help…
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Reducing Cross-Contamination Risks in Process Chromatography
All of the attributes of single-use technologies--reduced process time, faster equipment turnaround, greater manufacturing flexibility, and reduced risk of cross contamination--apply to chromatography…
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Development and Future of Protein A Chromatography Technology: Q&A with Jonathan Royce, Business Leader Chromatography Resins, Cytiva
This week Process Development Forum talks about Protein A with Jonathan Royce, business leader for Cytiva chromatography resins.
mAb purification platforms are very well established, and …
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Being Thorough When Transferring Technology
Another example would be to define materials that must be free of animal-derived products ahead of time, to prevent sources of viral contamination. Other procedures should also be established to defin…
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Downstream Processing for Cell-Based Therapies
Moreover, given the detachment procedure is undertaken in situ, it eliminates the need for an additional processing step outside of the culture vessel, reduces contamination risk, and decreases time b…
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Single-use Bioreactors Have Reached the Big Time
“With the range of disposable sensors now available, it is possible to obtain key data in real time without the risk of contamination because physical samples no longer need to be taken from the biore…
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Advancing Single-Use Technology Through Collaboration
By working together to harmonize the highly variable steps within the biopharmaceutical manufacturing process, both end users and suppliers are making strides toward the efficiency and integrity of …
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Perfusion in the 21st Century
Quality, flexibility, and cost savings are driving use of perfusion technology in biosimilars manufacturing.
By Bruce Lehr, Delia Lyons
Cell-culture technology for biopharmaceutical manufact…
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Analysis of Glycosylation in Biosimilars
…Sephadex beads, for example, in the purification process, and high mannose levels may indicate yeast contamination.
With this information in hand, the next steps are to study the glycoprotein mor…
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Antibody Production in Microbial Hosts
In addition, viral contamination of a therapeutic protein preparation can be altogether avoided with cultivation in microbial system. While mammalian systems have been predominantly used for the expre…