Search results for " system"
Article
Get Confident: Inline Conditioning Control Modes
The control modes are the system’s dynamic feedback functionality. The course consists of both instructional videos and cases that give a deeper understanding of the control modes.
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Mechanistic Modeling: Current Advantages and Future Opportunities in Biopharmaceutical Process Development
Also, ChromX offers multiple helpful features, including the ability to facilitate data import from ÄKTA™ systems and finding correlations between process parameters and quality attributes. But t…
Resource
Protein A Fiber Chromatography from Research to Scale-up and Manufacturing of Monoclonal Antibodies
The compatibility of fiber units with current chromatography systems regarding system flow rates, back pressure limitations, and dead volumes will also be demonstrated. Productivity, throughput, buffe…
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Eliminating Residual Impurities Starts with a Strategic Plan
Others are more complex to define, such as those that originate from the cellular system including residual DNA or host-cell proteins (HCPs),” Wake observes. “In the latter case, for instance, conside…
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The Need for Advanced Process Modeling for New Therapeutic Biologics
While QbD does not define manufacturing design space or specific protocols, it does discuss the need for a systematic approach to drug development and manufacturing. FDA believes that a QbD approach, …
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Fortem: One Film for Single-Use Bioprocessing
Single-use bags can now be found at every stage of bioprocessing: bioreactor and mixing systems, harvest and collection, purification, and liquid and powder storage and transportation. Thus, Cytiva ha…
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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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Emerging Therapies Test Existing Bioanalytical Methods
Since 1990, due to improved understanding of the human genome, proteome, and immune system along with improved drug delivery processes, the safety, efficacy, and applicability of cellular and gene the…
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Leveraging Computational Models of Glycosylation for Biopharma QA
To solve flux models, steady state is assumed, and the resulting system of linear equations is solved for the rates (fluxes) at which all TGPs are interconverted. Because the resulting system of linea…
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A Look at the Affinity Chromatography Landscape
With the advent of next-generation biopharmaceuticals, chromatography material suppliers have been challenged to develop affinity ligands and support systems that enable the separation and purificatio…