Search results for " method" 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…
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Generating a Fully Processed Antibody
The GPEx method is based on the use of replication-defective retroviral vectors (retrovectors) to actively insert the desired genes into the genome of dividing cells. By controlling the number of retr…
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Combining Microbioreactors and Advanced Statistical Techniques to Optimize a Platform Process for a New Host-Cell Line
The CLC rounds each used slight variations of the CLC method. The ability of PCA to distinguish between the rounds indicated that the method was summarizing biologically relevant behavior.
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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…
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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…
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Biosimilars Will Bring Significant Litigation and Patent Challenges
This trend is expected to continue, Ropka says, and she believes that biosimilar sponsors will be more willing to challenge patents related to the method of making and purifying drugs over molecule pa…
Article
DoE Provides Benefits, but Preparation Is Necessary
…armaceuticals, it is important to bear in mind that there are also limitations to consider with this method.
Two main challenges, asserts LaBrenz, include the fact that sampling of an adequate de…