Search results for " methods"
Article
Putting Viral Clearance Capabilities to the Test
Process understanding and careful assessment of risks are essential in developing viral clearance programs.
By Rita C. Peters
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Biopharma Says It Has an Evolution in New Technologies and Processes
This week, the Process Development Forum interviews Rita Peters, editorial director of BioPharm International, about Interphex 2018.
At the 2018 Interphex trade show in New York City in April…
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Flow Accuracy and Gradient Performance of ÄKTA pilot 600 Chromatography System
A comparable flow accuracy between scales can facilitate scaling of your methods.
In this application note, we demonstrate the flow and gradient formation of the ÄKTA pilot 600 chromatograph…
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Making the Move to Continuous Chromatography
“PAT and analytical methods that allow a process to continue running while providing feedback on critical quality attributes of a particular purification step have not evolved at the same rate as thei…
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Modern Manufacturing Key to More Effective Vaccines
In commenting on the effectiveness of this year’s flu vaccine, Gottlieb noted that products made with cell-based methods appear more effective in protecting against the H3N2 virus than egg-based produ…
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Applying GMPs in Stages of Development
Areas to be reviewed to determine the appropriate level of control needed in concert with the phase development stage include: level of validation of test methods, level of detail needed in batch reco…
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FDA Framework Spurs Advanced Therapies
The reason: with current available technology, early-stage clinical material will for the most part be manufactured with manual, small-scale methods. “Parallel development of processes that provide up…
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What's in Your SOP?
* Combination: A combination SOP uses multiple methods, such as both words and pictures, to communicate to the user the critical information in the SOP and the order in which the steps are to be perfo…
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Concentration and Buffer Exchange Using the Automated, Single-Use ÄKTA™ readyflux System
The process was conducted in an automated manner based on methods created using phases predefined in the UNICORN™ system control software. Concentration of 5 g/L bovine serum albumin (BSA) was perfor…
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Handbook: Design of Experiments in Protein Production and Purification
Design of experiments (DoE) is a technique for planning experiments and analyzing the information obtained. The technique allows us to use a minimum number of experiments, in which we systematically v…