Analysis of Host Cell Protein

11 articles
Why mAbs call for orthogonal HCP analysis techniques

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,...

May 21. 2021 | Thomas Kofoed |

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...

Mar 30. 2021 | Ejvind Mørtz |
Adenovira - Gene therapy analysis

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...

Dec 2. 2020 | Ejvind Mørtz |

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...

Sep 25. 2019 | Ejvind Mørtz |
ELISA coverage

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...

Jul 10. 2019 | Ejvind Mørtz |

What are Host Cell Proteins (HCPs)?

Question: What are HCPs and how are they measured? I recently met the term Host Cell Proteins (HCPs) in relation to process...

Jan 10. 2019 | Ejvind Mørtz |
1000 proteins quantified in e. coli mock lysate - HCP

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...

Jun 25. 2018 | Ejvind Mørtz |

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...

May 28. 2018 | Anette Draborg |
What is SWATH?

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...

Jun 22. 2017 | Thomas Kofoed |
Analysis method for Mw HCPs (small HCPs) below 20 kDa

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...

Oct 11. 2016 | Ejvind Mørtz |

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...

Oct 2. 2009 | Ejvind Mørtz |
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