Search results for " activity"
Article
Ensuring Sterility in Small-Scale Production
Susan Schniepp, distinguished fellow at Regulatory Compliance Associates, discusses how to ensure sterility when manufacturing small-scale parenteral batches.
By Susan J. Schniepp
Q. I am a …
Article
Impact of Manufacturing-Scale Freeze-Thaw Conditions on a mAb Solution
(38), wherein slow thawing conditions caused higher protein degradation and loss of activity (38).
One key finding from this work is that fast freezing followed by slow thawing resulted in g…
Article
Ensuring the Biological Integrity of Raw Materials
By Catherine Shaffer
Contamination with microbes, mycoplasma, viruses, and other adventitious agents can be a significant problem in biopharmaceutical manufacturing. Although contamination can o…
Article
Protein Purification Troubleshooting Guide
Practical advice to significantly impact your chromatography workflow
Put this poster on your lab wall to quickly identify and resolve protein purification problems when and where they happen. I…
Article
Drug Quality Key to Innovation and Access
FDA plans to advance initiatives for ensuring reliable production of drugs and biologics in 2017.
By Jill Wechsler
Amidst multiple challenges to the structure and governance of the US health…
Article
The Tide Stays High
The valuations and levels of public offering activity in 2014 and 2015 were not sustainable, and the NBI has never gotten back close to the levels it reached in 2015. Nevertheless, fundraising by emer…
Article
Biosimilars to Drive Modern Manufacturing Approaches
Reliable, high-quality products require innovative analytics and production.
By Jill Wechsler
As more biosimilars gain market approval in the United States, and manufacturers launch addition…
Article
Improving Process-Scale Chromatography
“Dynamic control carefully monitors effects of ion activity as well as concentrations in stock solutions and the final buffer so that buffer variability can be compensated for in line through adjustme…
Poster
Validation of Cytodex™ Gamma microcarrier-based virus production in single-use bioreactor systems
The results show virus titer activity was comparable for Cytodex and Cytodex Gamma and there was no observed difference in distribution or cell growth between systems.
Article
Real Time Continuous Microbiological Monitoring
Laser-induced fluorescence, a rapid microbiology method for real-time airborne particle and microbial monitoring, enhances sterility assurance in pharmaceutical manufacturing.
By Claudio Denoya …