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 ELISA kit have sufficient coverage? My company uses a commercial HCP ELISA kit for host cell protein...

Jul 10. 2019 | Ejvind Mørtz |

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...

Jan 10. 2019 | 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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