Search results for " purity"
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Reviewing the Importance of Biosimilarity and Interchangeability
He explains that, for comparability, the biosimilar needs to demonstrate similarity to the reference product in terms of structure, function, purity, and potency. Analytical methods should thus be cho…
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In silico optimization of AAV full/empty particle separation with AIEX
The separation of adeno-associated virus (AAV) with high yield and purity is an increasingly important challenge. Mechanistic modeling is the tool of choice to find the optimal AIEX chromatogr…
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Purification strategies for antibody-derived entities: bispecifics and fragments
Purification platforms used for many monoclonal antibodies (mAbs) need to be adopted for antibody variants to simplify protocols and improve purity and yield. The safety and efficiency requirement of …
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Top Tips for Successful Development of Antibody Chromatography Processes
But working with protein L, that only binds kappa subclass one, three and four, for instance, MabSelect™ VL, you could get a really high purity sample during the capture step. Since the lambda heterod…
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Discovering the unknown: How does in silico process development change PD scientists’ work?
This resulted in improvements in purity and yield of a mixed mode chromatography purification step, and doubled productivity. Mechanistic modeling can also support early-phase development. The technol…
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As the therapeutic pipeline diversifies, chromatography toolboxes are expanding.
Depending on the structure of the target antibody and the impurity profile, other affinities, like protein L or variants of protein A, may improve purity and increase removal of impurities.
Cytiva…
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Chromatography for the Diversified Antibody Pipeline
I believe we have an intense program on trying to address all the different aspects to receive good purity of the future drugs. The full process of an interaction depends on the amount of water consum…
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Report from the 12th Plasma Product Biotechnology Forum
One of the conclusions from the study was that with just six calibration runs, the model could predict the evolution of yield and purity for different starting materials. The general trend was conside…
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A better way to purify small drug volumes
But purifying viral vectors with methods optimized for other products can affect yield, purity, and cross-contamination.
How does the ÄKTA ready™ 450 system tackle those problems?
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Cell-free Expression Systems Pose Cell Culture Alternative
New technologies for rapid, in-line assessments of product concentration, potency, and purity are also needed. Meanwhile, new analytical, quality assurance, and regulatory approaches are needed to imp…