Document removal of process-related residual proteins in all purification steps

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 mass spectrometry - for both identification and quantification of...

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

Identification of small host cell proteins (low Mw HCPs)

Question:   Could you suggest an analysis method to detect low Mw HCPs (small HCPs) below 20 kDa? I work on a drug...

Oct 11. 2016 | Ejvind Mørtz |
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