Search results for " concentration" in Articles / App Notes
Article
Reconciling Sensor Communication Gaps
Further on the single-use trend, the biggest gap in downstream monitoring and control is the lack of appropriate single-use sensors beyond the standard devices for pH, conductivity, and product concen…
Article
Continuous Processing for the Production of Biopharmaceuticals
The configuration (Figure 1) has the ability to perform refolding at a much higher concentration and offers lower processing time compared with a corresponding batch process (22, 31). The dynamic mixe…
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Tools for Continuous Bioprocessing Development
A combination of perfusion flow and cell density control enabled process optimization of various parameters, such as inducer concentration and perfusion flow rate. Cultures were also shown to be stabl…
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Best Practices in Qualification of Single-Use Systems
As a result, they are susceptible to attack by organic solvents as well as acids and bases; some, at high concentrations, can even dissolve polymers. Because biomanufacturing may involve processing of…
Article
Fluid Handling in Biopharma Facilities
Industry experts discuss challenges, trends, and innovations in fluid handling.
By Susan Haigney
Contamination prevention in biopharmaceutical manufacturing is crucial, and the proper handling…
Article
Use of Multivariate Data Analysis in Bioprocessing
…ned media, and the authors concluded that significant chemical changes in terms of cysteine/cysteine concentration occur even when media are stored in the dark at 2-8 °C.
A general workflow for b…
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Ligand-Binding Assays and the Determination of Biosimilarity
FDA, in its May 2014 draft guidance on how to show biosimilarity using clinical pharmacological data, indicated that LBAs, concentration and activity assays, and PD assays were important for biosimila…
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Challenges of Protein Aggregation During Purification
“Aggregate formation is generally dependent on the solution conditions (conductivity and pH), protein concentration, and temperature. In addition, aggregates can be soluble when relatively small and i…
Article
Defining Critical Quality Attributes for Monoclonal Antibody Therapeutic Products
Figure 8A illustrates the levels of site-specific methionine oxidation measured by LC-MS peptide map in the presence of increasing concentrations of an oxidizing agent. This study found that although …
Article
Elucidating Biosimilars Characterization
…hose for classical medicinal-chemistry small-molecule products and are based on a comparison of peak concentration, time-to-peak concentration, area under the concentration-time curve; however, depen…