Search results for " Quality attributes"
Article
Understanding Validation and Technical Transfer, Part 3
For example, the impact of raw material variability or commercial-scale processing conditions on quality attributes may not have been fully determined. These factors are usually related to production …
Article
Continued Process Verification for Biopharma Manufacturing
In general, the nature and extent of CPV should be aligned with the outcomes of process qualification by focusing attention on aspects of processing that are most important to determining the quality …
Article
Digitalization: The Route to Biopharma 4.0
Researchers have attempted to create mechanistic models that can predict the impact of major process variables (5) on the critical quality attributes (CQAs) (6); however, these mechanistic models are …
Article
Bioburden Control in the Biopharmaceutical Industry
Cholayudth, “Application of Poisson distribution in establishing control limits for discrete quality attributes”, J. of Validation Technology 13(3)196-205(2007).
8. S. Sutton, “Sterility Tests” …
Article
Biopharma Advances Demand Specialized Expertise
Jun 15, 2015
By BioPharm International Editors
BioPharm International eBooks
Volume 28, Issue 13
Contract service providers share insights on biopharma market developments and the impl…
Article
Biomanufacturing Outsourcing Globalization Continues
May 02, 2015
By Eric S. Langer
BioPharm International
Volume 28, Issue 5
Biopharmaceutical manufacturing clusters continue to emerge outside of the traditional hubs of North America …
Article
DoE Provides Benefits, but Preparation Is Necessary
“The quantitative models for these multiple quality attributes can then be used for global optimization of the formulation, leading to more robust formulation development,” she says. Nguyen also notes…
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Regulation of Biosimilars: A Matter of Variability, Similarity, and Comparability
It is, therefore, important to have a systematic and quantitative assessment of quality attributes to pick out those that are crucial based on their clinical relevance. These critical attributes are o…
Article
Implementing QbD in Sterile Manufacturing
Critical quality attributes
BioPharm: In implementing a QbD approach, what would you identify as the critical quality attributes (CQAs) in sterile manufacturing and aseptic processing?
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Article
Monitoring and Control of Inline Dilution Processes
Monitoring and control
When looking at the buffer preparation process, the target product profile should be defined first followed by critical quality attributes and critical process par…