Search results for " method" in Articles / App Notes
Article
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…
Article
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…
Article
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…
Article
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…
Article
Platform Technologies Improve Protein Expression
In addition to exploring novel production methods such as continuous processes and disposable production technology, manufacturers also heavily invest in platform technologies for protein expression t…
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N-Glycan Analysis of Biotherapeutic Proteins
This article summarizes the approaches, challenges, and future perspectives for the characterization of N-glycans in biopharmaceutical products.
By Aled Jones
Protein glycosylation, the addi…
Article
From Darwin to Recombinant Fc Multimers
McCann talked about the potential of a DNA-based multiplex method that allowed analysis of up to 1,300 plasma proteins in a single sample.
The Markets, Policies and Strategies session, chaired by…