Search results for " cell"
Article
Advancing Single-Use Technology Through Collaboration
Silicone tubing, capsule filters, tissue culture flasks, and high-density cell culture equipment are just some of the types of single-use components that have been in use for decades. Single-use syste…
Poster
Process economy effects of modernizations in vaccine purification
This poster describes the technique using influenza virus produced in MDCK cells as a model system.
Poster
Integration of continuous upstream and downstream operations in mAb production
We describe the integration of a high-performing upstream cell culture process with downstream purification utilizing emerging technologies such as periodic counter-current (PCC) chromatography and st…
Article
Resolving a bottleneck in screening and characterization of recombinant antibody fragments using Biacore 4000
Ten 96-well plates containing avian scFv fragments in crude cell lysates were screened and ranked in less than 20 h. A subset from this screen was selected for analysis with the 2-over-2 kinetics appr…
Article
Lessons Learned Accelerate Vaccine Development
“The lack of true platforms, with a few exceptions, means that there is a lack of standard cell lines with associated process and analytical frameworks for the manufacturing and release of products,” …
Poster
Modes of controlling charge variant distribution in Mab production
In this study, we investigated the effects of cell culture process parameters and medium components on charge variant distribution of a human IgG1 MAb. Furthermore, the MAb charge variant clearance in…
Article
Automated harvesting and 2-step purification of unclarified mammalian cell-culture broths containing antibodies
We report on a new integrated platform for automated harvesting of whole unclarified cell-culture broths, followed by in-line tandem affinity-capture, pH neutralization and size-exclusion chromatograp…
Article
Breakthrough Drugs Raise Development and Production Challenges
For biologics, breakthrough designation may prompt greater focus on the reliability of the Phase I cell line, process and formulation, as shorter pivotal trials may truncate optimization of the Phase …
Article
Biosimilars Will Bring Significant Litigation and Patent Challenges
May 04, 2015
By Randi Hernandez
The risks involved with patent suits may become a bit more undesirable, thanks to new legislation aimed at deterring unreasonable patent suits. A senate bill…
Article
Vaccine Development and Production Challenges Manufacturers
Novartis’ vaccine plant in Holly Springs, NC was recently licensed to produce Flucelvax using mammalian cell culture. But the plant’s future is murky following Novartis’ divestiture of most of its vac…