Search results for " separation" in Articles / App Notes
Article
Use of Multivariate Data Analysis in Bioprocessing
Recently, researchers have described an application of MVDA towards development and optimization of a reversed phase (RP)-HPLC method for separation of metaxalone from its hydrolytic impurities (23). …
Article
Elucidating Biosimilars Characterization
Characterization of glycosylation is still a significant analytical challenge although recent advances in analytical instrumentation and separation chemistries have benefited the field considerably. G…
Article
Strategizing for Rapid Changeovers in Biologics Manufacturing
Olivier Le Moal/Stock.Adobe.com
By Cynthia A. Challener
Facility and equipment design are important, but the team and its experience matter most.
Through its Operation Warp Speed pro…
Article
Nurturing Knowledge from Disparate Data Streams
Spectra must be collected and separation analyses performed. The data obtained must be generated as a table, chart, or other picture that describes the results, which must then be compared to referenc…
Article
Development of Purification for Challenging Fc-Fusion Proteins
A capillary electrophoresis system (Beckman Coulter) applied high voltage to a capillary, and the electric charge caused separation by size using an UV detector to measure absorption.
Hig…
Article
Mechanistic Modeling of Preparative Ion-Exchange Chromatography
Figure 3: Modeling of separation of charge variants following ion-exchange process chromatography. The graph in (A) shows the reconstruction of a peak from high-performance liquid chromatography analy…
Article
Analysis of Glycosylation in Biosimilars
The use of specific proteolytic digestion procedures, in conjunction with chromatographic separation, allows the isolation of glycopeptides, which can then be analyzed using the techniques above to de…
Article
Selecting the Right Viral Clearance Technology
“Column chromatography will frequently be effective for virus reduction, but the degree of reduction is dependent on the resin type (mode of action), the conditions used for the separation, and the ch…
Article
Detecting Protein Aggregates and Evaluating their Immunogenicity
…anently, but through bonds that can be broken by ionic processes, means that we need to rely on both separation and detection,” which makes it especially difficult.
Aggregation risk factors
C…
Article
Determining Criticality–Process Parameters and Quality Attributes Part III: Process Control Strategies—Criticality throughout the Lifecycle
The author applies the continuum of criticality to develop the process control strategy and move through Stages 2 and 3 of the new process validation lifecycle.
With the most recent FDA …