Search results for " variability" in Articles / App Notes
Article
Strategizing for Rapid Changeovers in Biologics Manufacturing
“This challenge is more likely to apply to drug substance rather than drug product because drug substance processes typically have significantly more variability between different products,” Shave not…
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Technology Innovations Improve Process Chromatography Performance
He adds that variability in raw materials can present serious issues that impact downstream efficiency and can lead to long investigations and potential delays in making drugs available for patients. …
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Flexible Facilities for Viral Vector Manufacturing
“There is quite a bit of variability when it comes to viral vector manufacturing scales. It depends on the use of the vector (i.e., is it used as a reagent, as in the case of gene modified cell therap…
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Maximizing the Effectiveness of Upstream Bioprocessing Through the Combination of Lab Informatics and Instrumentation
With a scale-out rather than scale-up approach to meeting production requirements, there is a greater risk of variability in process conditions and product quality between individual bioreactors. Bior…
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Moving PAT from Concept to Reality
“Regulators expect process monitoring and controls based on the entire batch data and the ability to revise controls to compensate for raw material variability or the use of different batches of raw m…
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Cytiva Announces Digital Collaboration with Amgen To Improve Biomanufacturing Performance Reliability
Cytiva announced a digital data exchange collaboration program with Amgen, which will include advanced data analytics to increase the understanding of the relationship between raw material variability…
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Optimizing Late-Stage and Commercial Cell-Culture Processes
Cell-culture process innovations include platform processes with high productivity and chemically defined culture media, which have helped to reduce process variability and complexity, improve efficie…
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Understanding Validation and Technical Transfer, Part 2
Understanding Validation and Technical Transfer, Part 2
A validation plan developed to support a process unrelated to bio-pharmaceutical manufacture is applied to biopharmaceutical processes and sys…
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Understanding Validation and Technical Transfer, Part I
Codification of validation expectations and requirements was intended to reduce that variability.
The 1978 CGMP regulations (4) discussed validation in terms of automatic, mechanical, and elect…
Article
Preclinical Evaluation of Product Related Impurities and Variants
This may be attributed to the complexities related to the use of cell lines, media formulation, and other bioprocessing steps that are prone to variability to varying degrees (4).
The inherent …