Search results for " purity" in Articles / App Notes
Article
Efficient Purification of the Pertussis Antigens Toxin, Filamentous Haemagglutinin, and Pertactin in Chromatography Workflows
The described method resulted in higher purity and yield than what can be expected from a purification process based on salt precipitations and sucrose gradient centrifugation.
Download applicatio…
Article
A Platform Approach to Purification of Antibody Fragments
The described BioProcess™ resins offer high selectivity and excellent pressure-flow properties for high purity and yield in industrial-scale purifications. In addition, several case studies on purific…
Article
Analysis of Glycosylation in Biosimilars
Monosaccharide analysis can also give a purity check: high levels of glucose might suggest the breakdown of Sephadex beads, for example, in the purification process, and high mannose levels may indica…
Article
Design and Qualification of Single-Use Systems
The author provides a review of the concepts of design and qualification that apply to single-use systems.
By Jerold M. Martin
Single-use technologies (SUT) have made significant inroads in …
Article
An Integrated Approach to Ensure the Viral Safety of Biotherapeutics
Chemically defined raw materials have all components identified; components are in the chemical form, and the structure and concentration of all components is known and of high purity with only minima…
Article
Going Small to Achieve Success on the Commercial Scale
“Demonstration of both individual unit and linked unit output (recovery, product quality attributes, product purity, chromatographic profiles/transition analysis, etc.) comparability between small and…
Article
Selecting the Right Viral Clearance Technology
…on the ability to produce a purified protein that meets specifications and are developed to maximize purity with reasonable recovery. Only then is a chromatography step tested for viral clearance. “O…
Article
Best Practices in Qualification of Single-Use Systems
To ensure the drug product quality and patient safety, the SUS shall not be reactive, additive, or absorptive so as to alter the safety, identity, strength, quality, or purity of the drug product (11)…
Article
Use of Multivariate Data Analysis in Bioprocessing
Apr 06, 2015
By Anurag S. Rathore, Sumit K. Singh
BioPharm International
The ever increasing demand of biotherapeutics, together with the pressure to contain healthcare costs have motiva…
Article
Ensuring the Quality of Biologicals
monographs and general chapters for biologicals make reference to the use of chemical reference standards and biological reference preparations (BRPs) for identification, purity testing, and assay (co…