Search results for " attribute"
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Successfully Moving Regulated Data to the Cloud
In light of recent FDA guidance on data integrity, the challenges and benefits of using the public cloud to deploy and use data management software are discussed.
By Stuart Ward
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Real-Time Characterization of Biotherapeutics and Comparability of Biosimilars
This could be attributed to differences in expression system, culture conditions, purification processes, formulations, or storage conditions of the product and need to be suitably addressed as per th…
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A Look at the Affinity Chromatography Landscape
“Use of affinity chromatography has removed some of the burden on the purification steps downstream of the affinity step, allowing the focus to be directed toward specific attributes such as enrichmen…
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Achieving Process Balance with Perfusion Bioreactors
“It is important to design a process with a balanced feed rate that ensures the target is reached without compromising the critical quality attributes of the product,” he states.
Running longer pr…
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Recent Advances in the Use of Exoglycosidases to Improve Structural Profiling of N-glycans from Biologic Drugs
Thus, glycan structure is a critical quality attribute (CQA) that must be monitored during drug manufacturing.
Glycan composition profiling is commonly used to track the structural diversity of…
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A Look into the Future of Biopharmaceutical Quality
Schniepp (RCA): I think the quality unit will evolve to be a more hands-on review of the product attributes. The quality unit will need to be equal partners with manufacturing to be able to release pr…
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The Challenge of Disruptive Technologies in Bioprocessing
“Advanced automation also involves the use of trend analysis and correlations between ‘simple’ measurements and ‘complex’ quality attributes,” he says.
“This all helps to lower the cost of the …
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Biopharma Says It Has an Evolution in New Technologies and Processes
A significant roadblock to the implementation of continuous bioprocessing is the need for improved process analytics to measure critical quality attributes (e.g., protein function) in real time. Anoth…
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Making the Move to Continuous Chromatography
“PAT and analytical methods that allow a process to continue running while providing feedback on critical quality attributes of a particular purification step have not evolved at the same rate as thei…
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Techniques for Improving Process Development for Exosome-Derived Therapeutics
A myriad of attributes can be studied for a given population of exosomes. We want to focus on the ones that relate to the functional characteristics of exosomes and how they might behave from a safety…