Search results for "process understanding"
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Determining Criticality–Process Parameters and Quality Attributes Part III: Process Control Strategies—Criticality throughout the Lifecycle
With the most recent FDA (1) and Inter-national Conference on Har-monization (ICH) guidances (2-4) advocating a new paradigm of process validation based on process understanding and control of paramet…
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QbD and PAT in Upstream and Downstream Processing
BioPharm: Given the inherent variability in biologics manufacturing, how does QbD improve process understanding and control? What are the limitations of QbD in upstream bioprocessing?
McKnight (Ge…
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The Lifecycle Change of Process Validation and Analytical Testing
You can't successfully conduct these lifecycle activities without intimate process understanding. This is only achieved on a batch-to-batch basis through real-time in-line PAT. Where this is not possi…
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Continuous Manufacturing: A Changing Processing Paradigm
To properly deliver continuous manufacturing, a company must invest upfront in process understanding, he adds, and “with failure rate of products in the clinic, this could become a significant hurdle.…
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Mapping a Route for Cell and Gene Therapy Process Development
While cell and gene therapies differ in many ways, some of the best practices for process development and validation are similar.
By Cynthia A. Challener
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Assessing Manufacturing Process Robustness
The data-driven estimations allow for in-depth product/process understanding, proving product robustness, and are in line with regulators’ expectations that science and data be used for product and pr…
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Single-Use Technologies Prove Effective for Viral Vector Process Development
The benefits of single-use technologies for upstream viral-vector processes clearly outweigh their disadvantages.
Cynthia A. Challener
Upstream viral-vector processes can have sig…
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Addressing the Complex Nature of Downstream Processing with QbD
Nowadays, it is a structured methodology for how to approach product development that is not driven by regulatory need, but rather internal needs related to the establishment of process understanding,…
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Continued Process Verification for Biopharma Manufacturing
CPV serves to provide ongoing verification of the process design and aids in enhancement of process understanding providing the vital link shown at the left side of the inner circle in Figure 1.
F…
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Science Focus Fuels Successful Process Development for Startups
Getting the science right helps biopharma startups overcome development and commercialization challenges.
By Cynthia A. Challener
sdecoret/Stock.Adobe.com
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