Search results for " start" in Articles / App Notes
Article
Application of Quality by Design to Viral Safety
A QbD approach to drug development starts with the definition of critical quality attributes (CQA) that the final drug product will possess, and then outlines the development path to achieve these goa…
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Automated Concentration and Diafiltration of Multiple siRNA Samples
…P-HPLC) and liquid chromatography–mass spectrometry (LC/MS) are used to analyze the quality of the starting feed material and to assign lot specifications for further downstream purification.
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Top Tips for Successful Development of Antibody Chromatography Processes
So we’ll start with aggregates.
So let's assume that we have a starting platform, or a process, based on protein A, ion exchange step. So, a cation exchange step and an anion exchange step. …
Article
Visualize your ÄKTA Pilot 600S in 3D
When when thinking of getting a new system, add components and study 3D models of systems like ÄKTA pilot 600S, ÄKTA avant, ÄKTA pure, ÄKTA go, and ÄKTA start in Cytiva’s Puri…
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Next Generation Process Chromatography
The obvious step is to start with bind/elute operations where Fibro has a clear advantage over alternative convection flow adsobers.
I strongly believe that Fibro has a huge potential. We really a…
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The Importance of Partnering for Bioanalytical Studies
It is also preferable to start the method validation process early that ensures that the data are reliable. While FDA guidance suggest that the level of validation should be appropriate for the intend…
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Gene Therapies Push Viral Vector Production
“This makes it a popular starting point for gene therapy, although many serotypes continue to struggle with manufacturing challenges, such as low production yields and therefore high cost of goods,” T…
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The Need for Advanced Process Modeling for New Therapeutic Biologics
FDA believes that a QbD approach, similar to process modeling, should start with predefined objectives. There should also be an emphasis on product understanding and process control, and that the desi…
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Scaling Up Novel Therapies
“We’re already up by logs from where we were when we started our research,” she said.
Developers are actively exploring ways in which platform technologies could help improve the yield o…
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CDMOs Driving Emerging Bio/Pharma Success
It would take at least two years before that infrastructure could start making product, and much of that capacity would be underutilized. In short, the presence of a robust CDMO industry probably redu…