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 |

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 |
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