Search results for " verification" in Articles / App Notes
Article
Recent Advances in the Use of Exoglycosidases to Improve Structural Profiling of N-glycans from Biologic Drugs
When used in conjunction with glycan profiling workflows, these enzymes play a crucial role in verification of the glycan structures present on a biologic drug or other glycoprotein.
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Article
Understanding Validation and Technical Transfer, Part 3
…lified, processes validation studies are finalized, and ultimately continuous process monitoring and verification programs are implemented.
Process monitoring and capability studies are used t…
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CoAs Help Secure the Supply Chain
When a supplier is new, the results of the CoA are usually confirmed for each shipment of the material by performing independent verification of the CoA results. Once a history of reliable and accurat…
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Reducing Cross-Contamination Risks in Process Chromatography
Preparatory and post-processing steps such as column packing, validation of packed-bed efficiency, verification of endotoxin clearance, unpacking, cleaning of unpacked columns, etc., can also be elimi…
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Evaluating Surface Cleanliness Using a Risk-Based Approach
This model separates the various steps and activities of validation into three stages: process design, process qualification, and continuous process verification. Since then, the lifecycle model has b…
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Managing Residual Impurities During Downstream Processing
Test chapters that contain validated methods and associated reference standards facilitate method adoption following verification that they are suitable for a new purpose. Stakeholders are encouraged …
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Being Thorough When Transferring Technology
In judging the success of transfers, having historical data compiled from the process using a continued process verification solution that pulls quality control and batch record data will enable easy …
Article
Automating Bioprocesses
The IoT could also help enable continuous process verification (CPV) across the supply chain. Companies have been moving towards CPV rather than annual product reviews. Requirements are emerging, part…
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Single-use technologies in downstream process intensification
In bioprocessing, thorough cleaning is critical in order to take full benefit of the resin by removing impurities. When using conventional chromatography solutions, cleaning and cleaning validation …
Article
A Platform Approach for the Identity Testing of Multi-Component Cell-Culture Media
Any sample not identified through the combination of the described two non-specific identity tests can be subjected to folic acid analysis and quantity verification against established specifications …