Search results for "validation"
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The Importance of Process Intensification and PAT for Achieving Real-Time Release
One consequence of this emphasis on speed is increased demand for more efficient development and validation of faster analytical methods. Rapid inline or online methods that can provide results within…
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Reimagining Affordable Biosimilars
…drugs in a systematic manner using established, robust statistical processes that allow testing and validation of clinical hypothesis. For biosimilars, factors that significantly impact affordability…
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Biacore surface plasmon resonance application specialists are eager to share their experience in assay design, validation, and data evaluation.
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Technology Innovations Improve Process Chromatography Performance
Reducing the costs for cleaning and cleaning validation are also challenges that many big companies and contract manufacturing organizations (CMO)/contract development and manufacturing organizations …
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Good Manufacturing Practices: Challenges with Compliance
In addition, there is not a lot of guidance on how to handle mixtures of materials and what constitutes an appropriate method validation, especially for complex dosage forms which may contain other in…
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2019’s Top Bioprocessing Trends and What to Expect in 2020
QbD, Regulatory, and Validation Considerations
Viral clearance is a topic on the minds of many in the biopharma industry, and for good reason. Considering the manufacturing challenges experienced …
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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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Cell-Culture Advances Test Bioreactor Performance Models
“While some vendors already offer such sparger technologies, the industry has been slow to update to these sparger technologies, likely due to the revalidation burden of changes to established bioproc…
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Case Study: Virus Reduction of an Affinity Capture Step
Evaluating how much a process step contributes to viral clearance is an essential part of process validation. For this reason, there is an industry need to perform effective viral clearance studies. I…
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Ensuring Viral Safety of Viral Vaccines and Vectors
EMEA, Note for Guidance on Virus Validation Studies: The Design, Contribution and Interpretation of Studies Validating the Inactivation and Removal of Viruses. CPMP/BWP/268/95, (London, revised 1996).…