Search results for " traceability"
Article
Setting Up Bioprocessing Systems for Digital Transformation
There is also the issue with data tracking, so that the components used are assigned to the batch they are involved with, for traceability and any subsequent process investigations, Dr. Liddell states…
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Remote Monitoring and Big Data Advance Upstream Automation
Anywhere data integrity and traceability are critical, blockchain could be employed to provide unalterable records. Manufacturing data, chain of custody data, product lifecycle data, and many others c…
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Akron Bio Will Install a Cytiva FlexFactory to Manufacture Plasmid DNA
The FlexFactory, designed for cGMP manufacturing, provides traceability and optimization by combining control, connectivity, automation, and supporting services that accelerate manufacturing, accordin…
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Improving mAb Manufacturing Productivity by Optimizing Buffer and Media Prep Process Flow
Innovative approaches, including ready-to-use materials and in-line dilution, can significantly streamline overall bioprocessing operations.
By: Pranav Vengsarkar and Nandu Deorkar
I…
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Understanding and Controlling Raw Material Variation in Cell Culture Media
Manage variability through advanced analytical methods and risk-based assessment.
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The Evolution of Supply Chain Security: Increasing Focus on Raw Material Variability
An increase in the development of biological and patient-specific drugs has also reinforced the demand for heightened raw material control.
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Mapping a Route for Cell and Gene Therapy Process Development
It will be necessary to develop an automated closed system with a minimal footprint that can be placed in a cleanroom space yet still maintain material traceability (including chain of custody). Such …
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Best Practices for Selecting a Top-Quality Cell Line
“[These] data, along with the right bioinformatics, can allow for direct assessment of the clonality of the biotherapeutic production cell line and provide traceability, validation, and origin of cell…
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Nurturing Knowledge from Disparate Data Streams
Regulatory considerations have also now become intrinsically linked to the traceability, security, and non-corruptibility of scientific data, again resulting in difficulties with older equipment, he n…
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Recent Advances in the Use of Exoglycosidases to Improve Structural Profiling of N-glycans from Biologic Drugs
Finally, enzymes were manufactured under international quality management systems to ensure a high level of traceability and quality control.
Figure 4. A) Physical quality of comme…