Analysis of Host Cell Protein
13 articles
Quantifying HCP impurities in uncommon expression systems
Question: We use a plant-based expression system to produce our immunotherapy-based biologics. Unfortunately, since the expression system is quite unusual, commercial...
How to select an HCP ELISA with sufficient coverage for regulatory documentation
Question: How do I choose the best ELISA kit for my biologic? In other words, I would like to select the...
Critical reasons why mAbs call for orthogonal HCP analysis techniques
Question: We produce a monoclonal antibody (mAb) product, and our HCP ELISA shows low ppm levels. Recently, I heard that regulatory...
Investigation of ubiquitin in purified antibody products
Question: Should we worry about ubiquitin in our mAb? Our process-specific HCP ELISA did not detect Host Cell Proteins (HCPs) in our...
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...
How to document removal of a process related impurity
Question: How do I detect process-related impurity at low ppm levels? My company develops and produces a biologic. Recently, regulatory authorities asked...
Can I use commercial HCP ELISA kits in clinical trial documentation?
Question: Does our generic HCP ELISA kit have sufficient coverage? My company uses a commercial HCP ELISA kit to analyze clinical phase...
What are Host Cell Proteins (HCPs)?
Question: What are Host Cell Proteins, and how are they measured? I recently met the term Host Cell Proteins (HCPs) in relation...
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...
How do ‘Jackpot HCPs’ and a ‘Lucky Goat’ influence my ELISA results?
Question: Why do HPC ELISAs give different results? I tested two different HCP ELISA kits on my biopharmaceutical. Why do they give...
What is SWATH mass spectrometry and its advantages?
The mass spectrometry SWATH analysis can analyze host Cell Proteins (HCPs) in protein biopharmaceuticals. It provides both identification and quantification...
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 product...