Search results for " impurities"
Article
A Risk-Based Genetic Characterization Strategy for Recombinant CHO Cell Lines Used for Clinical and Commercial Applications
If not removed by the purification process, these unintended byproducts are typically considered product-related impurities (PRI), as defined by International Council for Harmonisation of Technical Re…
Article
Re-use of Protein A Resin: Fouling and Economics
…umn; capture of the mAbs from the harvest; wash step with the selective buffer to remove non-binding impurities; elution at low pH and conductivity; and finally, cleaning and sanitization of the colu…
Article
Tackling Analytical Method Development for ADCs
“Testing requirements will still be identity, purity, impurities, activity, concentration, and stability as outlined in the International Conference on Harmonization’s ICH Q5C (1) and ICH Q6B (2) biol…
Article
A Closer Look at Affinity Ligands
…CHO [Chinese hamster ovary] cells, followed by a series of steps to purify the antibody from all the impurities in the cell culture media. Following the removal of cells and cell debris from the medi…
Article
Digitalization: The Route to Biopharma 4.0
In another study, integrated process model correlating two process related impurities with two product-related impurities was developed to capture process development and design data and predict out-o…
Article
Chromatography for the Diversified Antibody Pipeline
If there is electrostatic interaction between chains, it is important to pair them efficiently so impurities are not left out.
Jeanne Linke Northrop:If we look at the polishing steps are t…
Article
Best Practices for Selecting a Top-Quality Cell Line
“A balanced plasmid ratio usually has dramatic impact on some formats of bispecific antibody cell line development to minimize impurities,” she explains. Factors such as cell growth and metabolism, as…
Article
Optimizing Late-Stage and Commercial Cell-Culture Processes
The security of obtaining supply for raw materials with the desired profile of contaminants and impurities is one example.
“With raw materials becoming ever more purified, trace levels of impu…
Article
Evaluating E&L Studies for Single-Use Systems
…GF/AAS) for silicone
• Inductively coupled plasma-mass spectrometry (ICP-MS) for elemental impurities
• Total organic carbon (TOC) on aqueous extracts only.
On-site asse…
Article
Process Chromatography Selection for Downstream Processing Applications
Becerra-Arteaga (MilliporeSigma): Ion-exchange chromatography is most commonly used to separate product- and process-related impurities in the purification of biologics that are not mAbs. In cases whe…