Follow levels of process-related residual protein in purification

Question: My company develops and produces a biologic. Recently, regulatory authorities asked us to document how efficiently downstream purification reduces the...

Sep 25. 2019 | Ejvind Mørtz |
ELISA coverage

Can I use commercial HCP ELISA kits for my clinical trial application?

Question:   My company uses a commercial HCP ELISA kit for host cell protein analysis of clinical phase 1 material. We hear...

Jul 10. 2019 | Ejvind Mørtz |

What are Host Cell Proteins (HCPs)?

Question: I recently met the term Host Cell Proteins (HCPs) in relation to process development and production of biopharmaceuticals. What are...

Jan 10. 2019 | Ejvind Mørtz |
What is SWATH?

What is SWATH & why is it an advantage in Host Cell Protein analysis?

Host Cell Proteins (HCPs) in protein biopharmaceuticals can be analyzed by the mass spectrometry SWATH analysis - for 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: I work on a drug substance protein with a mass of 15 kDa. I would expect small host cell protein...

Oct 11. 2016 | Ejvind Mørtz |
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