Search results for " expression" in Articles / App Notes
Article
Biosimilar Quality Requirements
Factors to consider include the expression system, the manufacturing process, physicochemical properties, functional activities, target binding, impurities, the reference product and reference standar…
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What’s New in Upstream Technologies
Bench-scale automated cell culture system
The scale-X carbo, from Univercells, is a bench-scale automated cell culture system for the expression and concentration of viral drug substance suited fo…
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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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Modeling the Degradation of mAb Therapeutics
They result in instabilities that can occur at various stages of product development, including upstream processing (during protein expression in cell culture), downstream processing (purification), p…
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Recent Advances in the Use of Exoglycosidases to Improve Structural Profiling of N-glycans from Biologic Drugs
Taron*is scientific director, Protein Expression and Modification Division, [email protected], Xiaofeng Shi is development group leader; both are at New England Biolabs. Pauline M. Rudd is a visiting inve…
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Manufacturing of Viral Vectors
As a vaccine platform, viral vectors can be used for the expression and presentation of pathogenic antigens to induce an immune response by mimicking a natural infection. Viral vectors can also be use…
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Ensuring Viral Safety of Viral Vaccines and Vectors
Ensuring Viral Safety of Viral Vaccines and Vectors
Viral vaccines and viral vectors used in biotherapeutic applications carry the risk of microbial contamination, which must be addressed.
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A Look into the Future of Biopharmaceutical Quality
As these advancements have occurred, new quality regulations have been developed to address the complex nature of biologics with specific quality requirements associated with viral safety, expression …
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The Challenge of Disruptive Technologies in Bioprocessing
The Challenge of Disruptive Technologies in BioprocessingIncreasing demand for biologics is driving the need for innovation in bioprocessing.
Jul 01, 2018
Increasing demand for biologics is drivin…