Search results for " cell" in Articles / App Notes
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…
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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…
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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,” …
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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…
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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 …
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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…
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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…
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FDA Approves First Biosimilar
Amgen is suing Sandoz for patent infringement (covering a method of using filgrastim to treat a disease requiring peripheral stem cell transplantation), unfair competition, and conversion, and tried t…
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Quality by Design and Extractable and Leachable Testing
Impact on cell culture might also be important, particularly for single-use fermentation bags, for example, and USP Biological Evaluation, In Vitro (3) would be a reasonable minimal CQA for which to …
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Setting Standards for Biotech Therapeutics in India
Many new general chapters pertaining to topics such as therapeutic monoclonal antibodies, host cell proteins and DNA, and viral safety are in the works for the next IP edition.
As mentioned previo…