Search results for " methods" in Articles / App Notes
Article
Downstream Processing for Cell-Based Therapies
Harvesting methods
The harvesting of cells is the process of removing the cells from the culture vessel after expansion. Given the wide variety of CGTs, an array of culture devices (stirred-tank b…
Article
Drug Quality Key to Innovation and Access
And pressure to combat the devastating opioid epidemic across the United States highlights the need for innovative methods to produce new formulations to treat pain that also resist abuse and misuse. …
Article
Biosimilars to Drive Modern Manufacturing Approaches
FDA officials are emphasizing how advanced analytical methods can document product performance similar to a reference drug, and that cutting-edge technology can ensure reliable production of high-qual…
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Advancing Single-Use Technology Through Collaboration
In addition, manufacturers had been generating their testing methods for single-use systems by extrapolating from their interpretations of the regulatory requirements for traditional systems. In order…
Article
Generating a Fully Processed Antibody
The authors outline cell-line development and process scale-up for an antibody program in which the antibody requires additional processing by a site-specific enzyme for correct functionality.
B…
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Combining Microbioreactors and Advanced Statistical Techniques to Optimize a Platform Process for a New Host-Cell Line
Use of a subspace model is a viable method to characterize process space variables and optimize process performance.
By Colin Jaques, Daniela Lega
Over the past decade, two improved capabili…
Article
Changing the Culture of Cell Culture: Applying Best Practices and Authentication to Ensure Scientific Reproducibility
…d lack of consensus on the level of detail required to allow adequate documentation of materials and methods in the literature to facilitate external replication of study results.
A search of NIH…
Article
Cleaning of Dedicated Equipment: Why Validation is Needed
…e too low and therefore the potential residues would not be detectable with the available analytical methods (2).
• The acceptance criteria are too low and cannot be achieved (i.e., for some high…
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
DoE Provides Benefits, but Preparation Is Necessary
“This single-point, continuous, data-point strategy is readily testable using most statistical methods,” LaBrenz explains. In addition, Nguyen notes that the generated stability data can be reduced do…