Search results for " purity"
Article
Preclinical Evaluation of Product Related Impurities and Variants
Statistical modelling using CEX content of each fraction as input and cell potency as output would help to parse the impact of each variant on cell potency without the need to isolate them in purity. …
Article
Techniques for Improving Process Development for Exosome-Derived Therapeutics
It can be difficult to isolate a large swath of the exosome population while achieving sufficient purity.
In the literature, the most commonly used approach for isolating exosomes is ultra-cen…
Article
Multidimensional Scale-Up of a Monoclonal Antibody Capture Step, Using ÄKTA™ pilot 600
Equivalent mAb recovery and purity was achieved between the larger and the smaller scales, showing a robust and scalable process.
Click here to view the application note.
Article
Development of Purification for Challenging Fc-Fusion Proteins
Process capacity determination with column chromatography
The screening above with the desired purity was used as a starting condition for small-scale column experiments at a higher load …
Article
Process Chromatography: Continuous Optimization
Improved resin chemistries and customized separation solutions are enabling more efficient separations.
By Cynthia A. Challener
Cell-culture and fermentation are high-…
Article
From Darwin to Recombinant Fc Multimers
…t, together with a QbD approach, delivered a robust process control strategy to deliver a high-level purity and quality recombinant VIIa (rhFVIIa) from a somewhat unusual expression system: milk of t…
Article
Managing Residual Impurities During Downstream Processing
Increased understanding of potential impurities has spurred efforts to standardize monitoring procedures.
By Cynthia A. Challener
Manufacture of protein and other biologic drug substances via …
Article
Improvements in Protein A Chromatography
Alternative technologies like CEX capture or precipitation often provide lower purity and require more mAb-specific development.
What future directions would you like to see in the development o…
Article
Critical Quality Attributes Challenge Biologics Development
While CQAs of small-molecule drugs can affect the purity, strength, drug release, and stability of a drug, the complex nature of biologics can create additional quality attributes that can affect the …
Article
Mechanistic Modeling of Preparative Ion-Exchange Chromatography
This specificity is of particular relevance to the production of biotech therapeutics, which require high standards of purity. However, development and optimization of a process chromatography step pr…