Search results for "Cytiva"
Article
Tools and Solutions for Separation of Charged mAb Variants
A biosimilar is an almost identical version of an originator product. To attain regulatory approval, a comparable quality to the reference product in terms of efficacy, purity, and safety should be …
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Process Development: What May Lie Ahead in 2018?
This article, Evaluating E&L Studies for Single-Use Systems, was one of the site’s most-read articles of 2017, as was a blog on how Cytiva aligned its extractables and leachables testing with the Biop…
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Driving Change in Biomanufacturing
Whatever the objective, driving change is a challenge. Implementing a new technology into a bioprocess is a big change. The new technology must be fully understood, all regulatory requirements fulfi…
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Bioburden Entry Points in Downstream Processing
If you work in bioprocessing, you are no doubt aware of the need to prevent bioburden entry and proliferation, and reduce the complexity of the equipment and processes involved. Anastasia Lolas, for…
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What You Need to Know about Continuous Processing
There is a lot of interest around continuous biomanufacturing, and it is expected to have a significant impact on the biomanufacturing industry over the next few years. Continuous processing can hel…
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Prepare for an FDA Bioburden Inspection
Even with effective prevention, bioburden incidents can occur. A best-practices response will not only help you be prepared for any upcoming FDA inspection, it may also yield valuable insights to help…
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Multidimensional Scale-Up of a Monoclonal Antibody Capture Step, Using ÄKTA™ pilot 600
Fast and efficient process development and scale-up contributes to a shortened time to market. In this work, a multidimensional scale-up (change of both column diameter and bed height) of a mAb capt…
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Connected Polishing and Concentration Under One Automation Method
Chromatography and tangential flow filtration (TFF) steps are traditionally performed as separate unit operations in downstream bioprocessing. This work aims to demonstrate the capability of the UNICO…
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Concentration and Buffer Exchange Using the Automated, Single-Use ÄKTA™ readyflux System
This work describes the capabilities of ÄKTA readyflux when used in ultrafiltration/diafiltration (UF/DF) applications. The process was conducted in an automated manner based on methods created …
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Performance of Single-Use Xcellerex™ XDR‑500 MO and XDR‑50 MO Stirred-Tank Fermentor Systems
This application note describes the performance of the XDR‑500 MO fermentor system in comparison with the XDR‑50 MO fermentor. Domain antibody production in E. coli was used as the model process. …