Search results for " system" in Articles / App Notes
Article
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, …
Article
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…
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Generate an Automated Purification Protocol in Three Steps Using Predefined Methods
Regardless of the chromatography technique you are using or if you are using a combination of techniques, UNICORN™ software used for ÄKTA™ systems provides years of purification experience built …
Article
Biopharma Seeks Balance
FDA actively encourages bio/pharma companies to embrace advanced manufacturing processes and incorporate newer technologies for established systems; however, the industry’s conservative approach to ch…
Article
Sanitization of ÄKTA™ pilot 600 Using Sodium Hydroxide
Sanitization of the system was performed by running the predefined method using 1 M sodium hydroxide (NaOH) as sanitization agent. The results show excellent cleaning efficiency, with a log reduction …
Article
Applying GMPs in Stages of Development
This procedure, regardless of whether the product you are investigating is biotech or traditional, or new or old, should require the investigator to review various systems and determine whether they w…