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…

Article 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…

Article 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 …

Article Being Thorough When Transferring Technology
Depending on the process requirements and the ability to chemically inactivate the cytotoxin, dedicated or single-use manufacturing equipment can eliminate the possibility of cross-contamination. …

Article 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…

Article 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…

Article Advancing Single-Use Technology Through Collaboration
Single-use systems minimize the risks for cross-contamination between batches, can be set up more quickly than traditional fixed systems, can lower operating costs per batch, and may allow for market …

Article Perfusion in the 21st Century
Such manufacturing sites generally have smaller reactors and are faced with the challenge of preventing cross-contamination. Regulatory agency interest in the greater process control and product consi…

Article Analysis of Glycosylation in Biosimilars
…ephadex 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 more…

Article 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…

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