Search results for " concentration" in Articles / App Notes
Article
Process Chromatography Selection for Downstream Processing Applications
This minimizes use of lyotropes and enables chromatography at higher salt concentrations thereby improving product economics. Furthermore, when used in a continuous mode, the effective ligand/ligate c…
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Host-Cell Protein Measurement and Control
Although it is a common understanding that HCPs pose clinical safety risk due to their potential to elicit an immune response, it is difficult to demonstrate which HCP and in what concentration may ca…
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Detecting Protein Aggregates and Evaluating their Immunogenicity
Higher concentrations of a protein formulation can increase the probability of aggregation, as well as changes in solution pH, temperature, buffer choice, agitation, and storage conditions. “Although …
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Predicting Progress in Protein Aggregation
If aggregation occurs during formulation, which is of particular concern for protein-based products that require high concentration, the performance and safety of the product can be affected. “There i…
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Evolution of the Monoclonal Antibody Purification Platform
As in HCIC, protein binding can take place at relatively less salt concentration, thus offering an alternative to HIC where high salt requirement for binding is a cumbersome operation. One such profil…
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Trends in Downstream Bioprocessing
…ovements and new products that enable purification and other downstream processing steps at a higher concentration of target protein, with a higher capacity for chromatography, or with higher concent…
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PDA's Technical Report for Biotech Cleaning Validation
The four principal cleaning-input parameters for each step are sometimes referred to as time, action, concentration, and temperature (TACT). These four parameters can vary, but in a controlled cleanin…
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Advances in Sterilization Technologies for Overcoming Viral-Vector Manufacturing Challenges
The high concentration of viral vector final formulations increases the challenges to process development and scaleup, adds Laux. “Effective control of LV formulation and a strong toolbox of various s…
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A Closer Look at Affinity Ligands
Release of the protein from the ligand is generally achieved by altering parameters such as pH, and sodium chloride concentration or by the addition of a competitor for ligand binding.
Shamlou (Ab…
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High-concentration monoclonal antibody drugs: manufacturing challenges
Manufacturing unit operations that are directly impacted by higher concentration formulations range from ultrafiltration to sterile filtration, filling, mixing and storage. Solutions that maintain qua…