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 |
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 |
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