Analysis of Host Cell Protein
11 articles
Critical reasons why mAbs call for orthogonal HCP analysis techniques
Question: HCP-ELISAs show our mAb is pure. So why do we need orthogonal analysis? We produce a monoclonal antibody (mAb) product,...
Investigation of ubiquitin in purified antibody products
Question: Should we worry about ubiquitin in our mAb? Our process-specific HCP ELISA did not detect any Host Cell Proteins (HCPs) in...
Why measure process-related impurities in gene therapies with LC-MS?
Question: Can I use mass spectrometry to document process-related impurities? I work in a biopharmaceutical company developing a gene therapy product...
Can I use commercial HCP ELISA kits in clinical trial documentation?
Question: Does our generic HCP ELISAs have sufficient coverage? My company uses a commercial HCP ELISA kit for host cell protein analysis...
Simple way to perform label-free quantification of Host Cell Proteins
Question: How can I improve label-free quantification of HCP? I find it difficult to get an accurate label-free quantification of Host Cell...
What is SWATH mass spectrometry and its advantages in HCP analysis?
Host Cell Proteins (HCPs) in protein biopharmaceuticals can be analyzed by the mass spectrometry SWATH analysis. It provides both identification...
Identification of small host cell proteins (small Mw HCPs)
Question: How do I identify HCPs with low molecular weight? I work on a drug substance protein with a mass of 15...
Host Cell Protein monitoring in process development – using mass spec
Mass spectrometry based Host Cell Protein identification and quantification The Mass Spec Host Cell Protein (HCP) assay is applied for monitoring...