Search results for " size-exclusion"
Article
Impurity Testing of Biologic Drug Products
Physicochemical methods can be largely based on compendial procedures and require little development, and parameters for platform techniques such as size-exclusion high-performance liquid chromatograp…
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Preclinical Evaluation of Product Related Impurities and Variants
In this case, reversed-phase high performance liquid chromatography (RP-HPLC) and size-exclusion chromatography (SEC) were used. While the former quantifies levels of the oxidized, f-Met, and reduced…
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Development of Purification for Challenging Fc-Fusion Proteins
Measurement of aggregation levels was determined by size-exclusion chromatography (SEC) using ultra performance liquid chromatography (UHPLC) (Waters) with Empower software that used an Acquity UPLC B…
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Being Thorough When Transferring Technology
Communication and taking the time to develop the process are key to successful transfer and scale up of biologics.
By Susan Haigney
Editor's note: The following is an extended version of the…
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Downstream Processing for Cell-Based Therapies
Assuming the microcarriers are not biodegradable and not part of the final product formulation, the next DSP step is likely to be the separation of cells by size-exclusion techniques. For example, dea…
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Improving Process-Scale Chromatography
This approach combines properties of size-exclusion and adsorption chromatography, according to Ljungqvist. She notes that the new resin has been found particularly suitable for vaccine processes; sma…
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Process Chromatography Selection for Downstream Processing Applications
Levison (Pall): [Some commonly used separation technologies include] ion-exchange, mixed-mode, hydrophobic interaction, and size-exclusion chromatography.
BioPharm: What are some new separation te…
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Automated harvesting and 2-step purification of unclarified mammalian cell-culture broths containing antibodies
We report on a new integrated platform for automated harvesting of whole unclarified cell-culture broths, followed by in-line tandem affinity-capture, pH neutralization and size-exclusion chromatograp…
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Host-Cell Protein Measurement and Control
With an additional separation dimension by high pH reversed phase, ion-exchange, or size-exclusion before LC-MS/MS identification, 2D-LC-MS reduces the interference from dominant peptides digested fro…
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USP Publishes Monoclonal Antibody Guidelines
The material is an IgG1, 2mg/vial lyophilized presentation, which is used in the size-exclusion chromatography assay (SEC) and the capillary sodium dodecyl sulfate (SDS) electrophoresis (reduced and n…