Search results for " contamination"
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…
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 …
Poster
A Next Generation Protein A Chromatography Resin for Improved Productivity and Bioburden Control
mAb production using a Protein A capture step has followed a highly successful synergistic path the last 30 years. There are, however, remaining challenges.
• The increased upstream titers in mA…
Article
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…
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…
Poster
Collaborating to address the bioburden challenge
At a minimum, bioburden contaminations lead to reduced productivity as a result of lost batches and/or deviation investigations. Striving towards a bioburden-free process, biopharmaceutical companies …
Article
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 …