Search results for " impurities" in Articles / App Notes
Article
What’s in your media? How costly is variability of cell culture media to your manufacturing process?
However, if there are several different components then there is an additive effect for impurities that are present. We also noticed that there are some components that trend and carry more materials.…
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Development of Purification for Challenging Fc-Fusion Proteins
Anion exchange chromatography (AEX) (6-8, 10-11), typically serves as a polishing chromatographic step operated in flow-through mode, binding process-related impurities such as HCP, DNA, leached ProA,…
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Reimagining Affordable Biosimilars
The manufacturing process itself serves as a producer of impurities and thus is a source of product heterogeneity. Characterizing and separating these impurities is essential for ensuring that product…
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Process Chromatography: Continuous Optimization
Even so, there are many impurities present in the harvest cell-culture fluid obtained after removal of the cells or yeast and media. Host-cell proteins, host-cell DNA, other process-related contaminan…
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Host-Cell Protein Measurement and Control
Risks Associated with HCPs
HCPs constitute a major group of process-related impurities in a drug product. The risks associated with HCPs are primarily immunogenicity. HCPs are complex mixtures wit…
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The Development and Application of a Monoclonal Antibody Purification Platform
…ated heterogeneous proteins (aggregates, degradation products, processing variants) and cell-derived impurities such as host cell protein (HCP) and cellular DNA. In response, platform purification pr…
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Updating Viral Clearance for New Biologic Modalities
Because viruses are typically smaller than downstream impurities such as host cell proteins (HCPs) and other extracellular debris, they require meticulous filtration, even in more established processe…
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Quality by Design and Extractable and Leachable Testing
This solvent component mixture is heated at elevated temperatures to extract all potential impurities out in a short period of time. These extracted chemicals are then identified by various analytical…
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Reviewing the Importance of Biosimilarity and Interchangeability
Identifying and quantifying impurities should include process-related impurities, degradation products, and contaminants. This is a crucial aspect of biosimilar development, Stamm notes. “Analytical m…
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Top Tips for Successful Development of Antibody Chromatography Processes
So it's the same impurities, but it's difficult not being able to go fast without running extensive process development. So it takes a long time to develop the process today because of this diversific…