Search results for " analyses" in Articles / App Notes
Article
Recent Advances in the Use of Exoglycosidases to Improve Structural Profiling of N-glycans from Biologic Drugs
In this approach, users input tables of UHPLCFLR-MS mobility, intensity, and mass data (ideally) obtained during profiling analyses. Exoglycosidase digestions result in large numbers of peak movements…
Article
Reducing Cross-Contamination Risks in Process Chromatography
When performing cost analyses, he adds, it is important to consider the cost of additional equipment such as steam generators that are required with stainless-steel equipment.
The flexib…
Article
Reconciling Sensor Communication Gaps
Whatever techniques are ultimately adopted, their ultimate goal must be to eliminate manual sampling and lengthy analyses, or at least, to streamline these operations so they become relevant within th…
Article
Evaluating E&L Studies for Single-Use Systems
• Many artifacts and analytical interferences were generated by strong/reactive solutions (as NaOH/NaClO), causing difficulties in the analyses and data interpretation; the use of strong saline/reacti…
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Walk Away and Do More Screening Preps
Many analyses require purified protein, and substantial hands-on time might be allocated to this task. Learn how an ÄKTA pure protein purification system can be modified to increase throughput of…
Article
Microbiological Testing: Time is of the Essence
For biologics, FDA is requesting studies to determine if drug substances or drug products demonstrate LER when performing endotoxin analyses (3). Due to the recent discovery of this phenomenon and the…
Article
A Risk-Based Genetic Characterization Strategy for Recombinant CHO Cell Lines Used for Clinical and Commercial Applications
…ch as a 1000-fold increase in transgene copy number (25)—more detailed DNA and amino acid sequence analyses may be necessary to ensure consistent product quality (3). In contrast, the GS-MSX expressi…
Article
Going Small to Achieve Success on the Commercial Scale
“There is a lot of documentation and analyses to complete, so in essence, qualification of scale-down models is often an exercise in coordination, rather than presenting a substantial technical challe…
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Changing the Culture of Cell Culture: Applying Best Practices and Authentication to Ensure Scientific Reproducibility
To fully characterize a cell line requires detailed genomic, proteomic, and phenotypic analyses, which remains implausible and costly for most cell banks, let alone typical research laboratories. For …
Article
Optimizing Cation-Exchange Chromatography with High-Throughput Process Development for mAb Purification
In HTPD, simple absorbance measures such as A280 measurements can be used, and additional analyses carried out for the most critical conditions. In this mAb case study, SBC increased by increasing pH …